All 123 reports in the Sept 1–30, 2026 window for the Titan inflatable penile prosthesis family (one of them is for the Titan accessory kit). Report numbers are shortened to their last five digits; the full number is 2125050-2026- followed by those digits, and you can look any of them up by report number in FDA's MAUDE database.
Read this first: These are reports, not failure rates. Nobody outside Coloplast knows how many Titans are implanted or in use, so a monthly count can't tell you how likely your device is to fail, and it can't be compared head-to-head with other brands. A report records what someone told the manufacturer; it isn't verified and doesn't prove the device caused the problem. A few describe surgeries from years ago, and one event can produce two reports.
TL;DR
- 72 of 123 reports (59%) were filed under Malfunction. The tubing stands out: of the 48 malfunction reports with a description, 20 involve the tubing (breaks, tears, cuts, leaks).
- "Fracture" was the most common problem code (31 of 72 malfunctions). When there's a description, it almost always means a broken or torn tube (18 of 20).
- Problems turned up at both ends of a device's life: 11 malfunction reports involve devices implanted in 2026, and 12 involve devices 10–21 years old.
- 13 infections, 8 of them in devices implanted in 2025–2026. Four ended with the device removed and nothing put back; three switched to a malleable.
- Also: 12 erosion/extrusion, 8 migration/placement, 6 sizing/dissatisfaction, 12 other.
- Not one device was documented as returned to Coloplast for analysis, so no report contains a confirmed root cause. Where the lot was checked (65 reports), the devices had "met specification" at release.
- Six reports say outright that the device itself was working fine (e.g. revisions for pain, size, a migrated reservoir or an extrusion).
1. Reports by category
Code: Select all
Category n % Desc
Malfunction 72 58.5% 48
Infection 13 10.6% 8
Erosion/Extrusion 12 9.8% 9
Other 12 9.8% 11
Migration/Placement 8 6.5% 4
Patient Dissatisfaction 6 4.9% 4
Total 123 100% 84"Desc" = the report includes a written description. 39 of the 123 (32%) have none, just FDA problem codes, so for those we know roughly what went wrong but not why or what happened next. The categories are the ones used in the export.
Health-effect codes: 89 reports are coded "No Clinical Signs, Symptoms or Conditions", yet 81 of those list a surgery year, so that code doesn't mean nothing happened to the patient. The rest list infection (13), erosion (11), pain (4), deformity (4), perforation (2), and one each of pus, wound breakdown, hematoma, urinary retention and calcification (a few reports carry more than one).
2. Malfunctions (72 reports)
2a. Problem codes
Code: Select all
Problem code n %
Fracture 31 43% ██████████
Fluid/Blood Leak 20 28% ██████▌
Inflation Problem 19 26% ██████
Pumping Problem 10 14% ███
Self-Activation 5 7% █▌
Insufficient info 4 6% █▌
Deflation Problem 3 4% █
Connection Problem 2 3% ▌
Material Deformation 2 3% ▌
Improper use/method 1 1% ▌
Material Rupture 1 1% ▌
Puncture/Hole 1 1% ▌
Split, Cut or Torn 1 1% ▌
Unintended Deflation 1 1% ▌A report can carry several codes, so these add up to more than 72. "Fracture" is the FDA code for a break; "Self-Activation or Keying" is the code used here for auto-inflation.
2b. What actually failed (the 48 malfunction reports with a description)
Code: Select all
What failed (48) n
Tubing 20 ██████████
Pump 7 ███▌
Won't inflate/stay up 6 ███
Leak, source unknown 5 ██▌
Cylinder 3 █▌
Reservoir 2 █
Connector 2 █
Auto-inflation 1 ▌
Patient-caused rupture 1 ▌
Unspecified 1 ▌- Tubing (20) is #1 by a wide margin. Where the report says which line, 5 were the cylinder-to-pump tubing (01580, 01628, 01642, 01648, 01675) and 2 the reservoir tubing (01629, 01668). Four give only a side or "at the pump" (01565, 01569, 01612, 01676), and nine just say "tubing".
- Tubing failures aren't only an old-device problem. Where both dates are known (15 reports), device age runs from the same year (01648, implanted 2026) to 12 years (01654), with a median of 4 years.
- Pump (7): a pump that collapsed and wouldn't refill (01578); a "defective pump" (only the pump was replaced, 01584); pumps not working (01658, 01660); pump difficulty plus auto-inflation (01601); a 2026 implant where the bulb goes hard after two squeezes (01679, still implanted); and pump trouble with auto-deflation where the parts worked fine once removed (01591).
- Won't inflate or won't stay up, no cause given (6): an 8-year-old device that wouldn't stay inflated (01531), two that wouldn't inflate (01550, 01598), a 2026 implant whose cylinders wouldn't inflate (01596), and two still implanted when reported (01639, 01646).
- Leaks or fluid loss, source not found or not stated (5): 01549, 01559, 01581, 01582, 01586. In 01586 an ultrasound showed no fluid left in the reservoir; 01582 was found fractured and empty; in 01559 it wasn't clear whether the tubing had a hole.
- Cylinder (3): a small hole in one cylinder (01597; the report notes he denied penile injections); a cylinder leak (01613); and a bubble-like bulge in the right cylinder that showed up as a skin bulge on inflation (01625), after which the whole system was replaced.
- Reservoir (2) and connectors (2): a reservoir leak in a 2006 device (01627); a reservoir down to 50 ml (01624); a "lack of connection" leak (01577); and a damaged reservoir-to-pump connection found at revision (01579).
- The rest (3): auto-inflation in a 2026 implant (01632); an implant "popped" by the patient, coded as improper use (01556); and an unspecified malfunction (01545).
2c. The 11 malfunctions in 2026 implants
- Revised the same year: tubing fracture, cylinder to pump (01648, TX); cylinders wouldn't inflate (01596, TX); auto-inflation (01632, SC); pumping problem (01572, PA); "material deformation" (01575, FL); leak with "split, cut or torn" material (01678, Jordan); no details (01635, TX).
- Still implanted when reported: leaking and losing pressure, with pain (01549); inflates only a little over halfway and is hard to deflate (01646); bulb goes hard after two pumps, follow-up booked (01679).
- No details: auto-inflation (01571).
3. Infection (13 reports)
- Timing: 8 of 13 were in devices implanted in 2025–2026 (6 in 2026 alone), which fits the usual pattern of implant infections showing up in the first months after surgery. Four were in older devices (implanted 2013, 2019, 2023 and 2024); one gives no year.
- Outcomes (8 with a description): 3 switched to a malleable: 01543 (pus in the scrotum, Genesis), 01567, and 01640 (the wound broke down and the pump was exposed). 4 were removed with nothing put back: three from South Korea with identical wording (01653, 01655, 01656) plus 01662, a 2013 device that was also protruding through the corpora. 1 was removed and later re-implanted with a new Titan Touch (01677).
- All 13 are coded "Adverse Event Without Identified Device or Use Problem": a complication with no device problem identified.
4. Erosion / extrusion (12 reports)
- Where: the glans (a pending erosion in 01542; thinning with extrusion in 01633, where the device still worked and a graft was added at replacement), the urethra (01558), a cylinder tip that appeared to have perforated the corpus cavernosum, along with a scrotal hematoma (01587), and the tubing connection extruding while the reservoir partly herniated into the groin and the device stopped inflating (01607). 01623 is a "proximal perforation", filed alongside leak report 01624. Three just say "erosion" (01547, 01557, 01626) and three have no description.
- Device age: 6 of the 7 with dates were 1–4 years old; the outlier (01626) was implanted in 2004.
- Outcomes: 6 removed and replaced; 1 got a temporary Genesis malleable for about six months to let the tissue heal, with a plan to re-implant a Titan (01587); 1 explanted (01607); 1 still in place (01542).
5. Migration / placement (8 reports)
- Reservoir migrated into the groin with "nothing wrong with the implant"; implant and reservoir replaced (01555, device from 2007).
- Cylinder "proximal crossover" in a 2026 implant; replaced (01583).
- Pump moved higher because the patient has dexterity problems and the pump sat too low and hidden (01630).
- Distal tips repositioned, in a revision done back in 2020 (01546).
- No details: malposition (01562, 2026 implant), migration (01563), migration with urinary retention (01621, 2026 implant), malposition with pain (01636).
6. Sizing / patient dissatisfaction (6 reports)
- Narrow-base 16 cm swapped for a regular-base 16 cm (01548).
- 20 cm swapped for 22 cm (01615).
- Too short, put down to a "floppy glans"; the same 20 cm size went back in, this time with rear tip extenders (01651).
- Patient wanted a bigger size / more fluid; the old device was working fine (01663).
- No details: size complaint (01533); "patient-device incompatibility" (01674, Thailand).
7. Other (12 reports)
- Calcification on the reservoir; replaced (01650).
- Tubing showing under the skin after weight loss; replaced (01659).
- Pain with a working device; replaced (01657, 2026 implant).
- Malfunction after an accident/injury; replaced (01564).
- Connector pieces from the accessory kit broke during the implant surgery; another kit was used (01631).
- Right cylinder tubing shortened and repositioned (01652).
- Patient says the implant left him with Peyronie's; the device inflates and deflates normally (01643).
- Revisions with no reason given: 01554 (switched to a Genesis), 01647, and two old Brazilian cases revised in 2017 (01585) and 2023 (01606).
- Wrong label, no details (01610).
8. How old were the devices?
Implant year to surgery year, all categories:
Code: Select all
Device age Mal Inf Ero Oth All
Same year 7 5 0 5 17
1 year 7 1 1 3 12
2-4 years 20 2 5 5 32
5-9 years 10 0 0 6 16
10-14 years 8 1 0 0 9
15+ years 4 0 1 1 6
No dates 16 4 5 6 31
Total 72 13 12 26 123Mal = malfunction, Inf = infection, Ero = erosion/extrusion, Oth = migration/placement, dissatisfaction and other. Years only, so each figure is ±1 year. "No dates" includes devices still in place.
- Malfunctions are spread across the whole lifespan: 14 in the same or the next calendar year, 30 at 2–9 years, and 12 after 10+ years of service, the oldest from 2005 (01538), 2006 (01618, 01627) and 2007 (01581). The median was about 3 years.
- Ten malfunction reports don't give an implant year; one of them (01612) is described as about 10 years old.
- Infections and erosions skew young: most of the dated ones happened within 4 years, but there's an infection in a 2013 device (01662) and an erosion in one from 2004 (01626).
- 25 of all 123 reports (20%) involve a device implanted in 2026: 11 malfunctions, 6 infections, 3 placement problems, 4 "other" and 1 dissatisfaction.
9. What happened to the patients
Code: Select all
What happened (84) n
Removed and replaced 60
Switched to malleable 6
Still implanted 6
Partial revision 5
Removed, none put back 4
Re-implanted later 1
Replacement not stated 1
Problem during surgery 1- Removal and replacement is by far the most common route (60 of 84).
- 6 ended up with a malleable, at least one only temporarily (01587). 4 were left with no implant, all of them infections.
- "Partial revision" means only one part was touched: tubing revised (01530), pump swapped (01584), tips or pump repositioned (01546, 01630), tubing shortened (01652).
10. Where the reports came from
Code: Select all
Country n
United States 86
Brazil (BR) 10
AU * 6
Jordan (JO) 5
Egypt (EG) 4
South Korea (KR) 4
Spain (SP) 4
RS * 2
IS * 1
Thailand (TH) 1- US by reporter state: FL 16, TX 12, NY 11, MI 5, NC 4; AL, SC, TN 3 each; GA, IA, IN, NJ, OR, PA 2 each; CA, CO, CT, ID, MA, NE, WI 1 each; not given 10. The state is where the initial reporter is based (often the surgeon or hospital), so it mostly reflects implant volume and reporting habits, not where devices fail more often.
- Brazil (10) includes two old events (revisions in 2017 and 2023). Brazil and Jordan wrote by far the most detailed descriptions, on average more than three times as long as US ones.
- South Korea (4): the three infections removed without replacement, plus a tubing leak in a 2014 device (01654).
- Jordan (5), Egypt (4) and Spain (4) were all malfunctions; Jordan's include the cylinder bulge (01625).
11. Patient ages
Age was given in 38 reports (37 patients, since 01600 and 01601 are the same man).
Code: Select all
Age n
Under 50 5 █████
50-59 10 ██████████
60-69 12 ████████████
70-79 10 ██████████Median 63, range 37–79.
12. What Coloplast's investigation found
- Devices returned for analysis: zero. The narratives say "not returned" / "not received", say the device is still implanted, or don't mention a return at all. Without the parts, the standard line is that Coloplast cannot comment on the condition of the device.
- Lot number known: 65 reports. All came back the same: devices met specification at release, no complaint trends, no linked nonconformances or corrective actions (CAPAs). One exception: the lot in 01597 (the cylinder with a hole) did have a nonconformance on file (NC-004170), which Coloplast says is unrelated to this failure.
- No lot number provided: 19 reports, so no manufacturing-record check was possible.
- No manufacturer narrative published: 39 reports.
13. Quirks in the data
- Not all of these are recent events. Five describe surgeries before 2026: 2017 (01585), 2020 (01546), 2023 (01606) and 2025 (01581, 01664). Reports get filed when the manufacturer hears about an event, sometimes years later.
- 123 reports ≠ 123 patients. At least two events were split into two reports each: 01600 + 01601 (auto-inflation + pump difficulty) and 01623 + 01624 (proximal perforation + reservoir leak).
- 01607 lists an explant year of 2027, which is impossible for a 2026 report; its own description says 2026.
- "Explant year" really means "year of the surgery": 01630 has one even though only the pump was moved and the device stayed in.
- The category labels don't always match the codes: 01662 (infection + erosion) sits under Infection, 01623 (perforation) under Erosion, 01652 (sizing) under Other.
14. Takeaways
- The tubing is the weak spot in this batch. Tubing breaks, tears and leaks are the most common described failure, and they turn up at every device age, from months to more than a decade.
- Trouble shows up early and late. One in five reports involves a 2026 implant (11 malfunctions including a same-year tubing fracture, 6 infections and 8 other issues), while a dozen malfunctions came after 10–21 years of service.
- Not every report means the device failed. Six reports say the device was working; the problems were pain, sizing, a migrated reservoir, an extrusion with a thinning glans, a pump complaint that didn't hold up once the parts were out, and a Peyronie's concern.
- No parts came back, so there are no root causes. If you're facing a revision, it's reasonable to ask your surgeon whether the old parts will be sent back to Coloplast for analysis; that's the only way Coloplast can confirm what went wrong.
- Anyone can report. Several reports appear to have started with a patient contacting Coloplast (e.g. 01639, 01643, 01646), and patients can also report problems directly to the FDA through MedWatch.
Not medical advice. If your device is losing rigidity, auto-inflating or hard to pump, or the area is painful, red, swollen or draining, talk to your urologist, and don't sit on signs of infection.
Source: manufacturer adverse event reports (MDRs) filed with the FDA by Coloplast for the Titan inflatable penile prosthesis family, Sept 1–30, 2026 export. All 123 reports were tabulated individually and cross-checked against the export; "Desc" = the report includes an event description. Device age = surgery year minus implant year (years only).
Appendix: every report at a glance
Grouped by category. Loc = US state ("US" if no state was given) or country code. Yrs = implant and surgery year, last two digits (?? = not given).
Code: Select all
Rpt Loc Yrs What happened
MALFUNCTION (72)
01530 FL 24-26 Tubing revision
01531 AL 18-26 Wouldn't stay inflated
01535 NY 12-26 Fracture
01536 RS 25-26 Fracture; infl./defl.
01537 NY 12-26 Fracture
01538 FL 05-26 Fracture
01539 TX 22-26 Fracture
01545 FL 25-26 Unspecified malfunction
01549 US 26-?? Leak, no pressure, pain
01550 TX 21-26 Would not inflate
01551 CT ??-26 Tubing break
01552 TX ??-26 Tubing tear
01553 RS 24-26 Tubing break, low fluid
01556 TN ??-26 Popped by patient
01559 TN 17-26 Leak, source unclear
01561 NY 15-26 Fracture
01565 NY ??-26 Possible tubing break
01568 NY ??-26 Tubing fracture
01569 TX 20-26 Tubing break, L to pump
01570 GA 16-26 Tubing tear
01571 US 26-?? Auto-inflation
01572 PA 26-26 Pumping problem
01574 EG 23-26 Leak + fracture
01575 FL 26-26 Material deformation
01577 SP 24-26 Connection failure, leak
01578 BR 23-26 Pump collapsed
01579 BR 23-26 Damaged pump connection
01580 TX 24-26 Tubing break, cyl-pump
01581 SP 07-25 Fluid loss; to Genesis
01582 BR 23-26 Fractured, empty; pain
01584 NJ ??-26 Defective pump replaced
01586 BR 24-26 Won't inflate; no fluid
01588 BR 23-26 Leak; inflation problem
01590 FL ??-26 Inflation problem
01591 AL ??-26 Pump trouble; worked OK
01592 NY 15-26 Tubing break
01596 TX 26-26 Cylinders won't inflate
01597 AU 24-26 Hole in one cylinder
01598 BR 17-26 Would not inflate
01600 NY 25-26 Auto-inflation (+01601)
01601 NY 25-26 Pump trouble (+01600)
01602 MI 14-26 No details
01612 FL ??-26 R tubing break, ~10 yrs
01613 TN ??-26 Cylinder leak
01614 NY 16-26 Fracture
01618 MI 06-26 Fracture
01619 US 19-26 Inflation problem
01622 JO 25-26 Leak + fracture
01624 IN 24-26 Reservoir 50 ml (+01623)
01625 JO 24-26 Bulge in R cylinder
01627 MI 06-26 Reservoir leak
01628 JO 21-26 Tubing leak, cyl-pump
01629 JO 25-26 Cut reservoir tubing
01632 SC 26-26 Auto-inflation
01635 TX 26-26 No details
01639 US 25-?? Won't inflate/deflate
01642 SP 17-26 Tubing break, cylinders
01646 US 26-?? Partial inflation
01648 TX 26-26 Tubing break, cyl-pump
01654 KR 14-26 Tubing leak
01658 SP 22-26 Pump not working
01660 EG 19-26 Pump mechanism failure
01661 EG 21-26 Pumping problem
01664 EG 24-25 Tube failure
01665 OR 24-26 Auto-inflation
01668 TX 22-26 Tubing leak to reservoir
01669 US 22-?? Inflation + pumping
01675 TX 22-26 Tubing break, pump-cyls
01676 MI 22-26 Tubing break, R at pump
01678 JO 26-26 Leak; split/cut/torn
01679 US 26-?? Bulb hard after 2 pumps
01682 AU 23-26 Fracture
INFECTION (13)
01532 OR 26-?? No details
01534 NJ 26-26 No details
01543 FL ??-26 Pus; switched to Genesis
01567 AL 26-26 Switched to malleable
01573 NY 19-?? No details
01640 TX 26-26 Pump exposed; malleable
01653 KR 26-26 Removed, not replaced
01655 KR 23-26 Removed, not replaced
01656 KR 25-26 Removed, not replaced
01662 IS 13-26 Protruding; not replaced
01670 PA 26-26 No details
01673 AU 24-26 No details
01677 CO 25-?? Later new Titan Touch
EROSION/EXTRUSION (12)
01542 IA 25-?? Pending, at glans
01547 ID ??-26 Replaced
01557 NY ??-26 Replaced
01558 IA 24-26 Urethral; replaced
01587 BR 25-26 Tip perforation; Genesis
01589 FL ??-26 No details
01607 BR 24-27 Tubing extruded; hernia
01620 NC 22-26 Malposition
01623 IN 24-26 Perforation (+01624)
01626 SC 04-26 Replaced
01633 CA 24-26 Thin glans; graft added
01666 NE ??-26 No details
MIGRATION/PLACEMENT (8)
01546 AU 16-20 Tips repositioned
01555 FL 07-26 Reservoir in groin
01562 TX 26-26 Malposition
01563 AU 25-26 Migration
01583 FL 26-26 Proximal crossover
01621 US 26-?? Urinary retention
01630 SC 23-26 Pump moved higher
01636 FL 25-26 Malposition; pain
PATIENT DISSATISFACTION (6)
01533 FL 23-26 Size inadequate
01548 FL 25-26 Narrow to regular base
01615 WI 23-26 20 cm swapped for 22 cm
01651 GA 19-26 Too short; RTEs added
01663 NC 18-26 Wanted bigger
01674 TH 26-?? Incompatibility
OTHER (12)
01554 US 23-?? To Genesis, no reason
01564 FL 22-26 Failed after accident
01585 BR 10-17 Revised 2017, no reason
01606 BR 17-23 Revised 2023, no reason
01610 MA 26-?? Wrong label
01631 MI 26-26 Kit broke during surgery
01643 US 25-?? Says caused Peyronie's
01647 NC 26-26 Right-side revision
01650 FL 21-26 Calcified reservoir
01652 AU 19-26 R tubing shortened
01657 NC 26-26 Pain; device was working
01659 FL ??-26 Tubing visible, wt loss