A detailed breakdown of all 265 reports filed for Boston Scientific's AMS 700 three-piece inflatable penile prosthesis family, 1–30 September 2026
Every report in the September listing was coded individually (device, failure mode, what was done surgically, implant and explant years, late-filing flags and lab findings) and then tallied in code. Counts of coded fields are exact; grouping reports by failed part and by outcome meant reading each narrative, so a few borderline cases are judgment calls. The full reports can be searched in the FDA MAUDE database.
Read this first. MAUDE reports show what kinds of problems get reported, not how often the device fails. There is no denominator (the number of AMS 700s implanted isn't part of this data), about a third of the reports have no description at all, and this month's total is swollen by a batch of late-filed older complaints. Nothing here is medical advice; your implanting urologist is the right person to ask about your own device.
At a glance
- 265 reports: 163 malfunctions (62%), 33 migration/placement, 23 "other", 22 infections, 14 patient dissatisfaction, 10 erosion/extrusion.
- A malfunction almost always meant another operation. 92 of the 96 malfunction reports with a description (96%) describe the device, or part of it, being surgically removed: 60 full exchanges, 22 partial exchanges, 7 removals with no replacement mentioned, 3 conversions to a malleable implant.
- "Won't inflate" plus fluid loss is the signature failure. Inflation Problem is coded on 84 of 163 malfunctions (52%), and 101 (62%) carry a leak, hole or air code. Where the narrative names the failed part: cylinder 27, pump 21, tubing 17, reservoir 4, connector 1, and 26 don't say.
- Typical device age at failure: half of the dated malfunctions happened within 5 years of implant (median 5 years, max 19; 139 reports with both years given). 40 (29%) were removed in the same or the following calendar year, and 14 (10%) lasted 10+ years. The oldest failed device was implanted in 2007 and removed in 2026, after 19 years.
- Infections and placement problems are mostly early events. Half of the infections (11 of 22) and of the migration/placement reports (17 of 33) involve devices implanted this year, in 2026. The longest gaps from implant to removal were 16 years for an infection and 8 years for a placement problem.
- Patients: median age 68, range 30–86 (age given in 236 reports). Malfunction reports match that (median 68, range 30–86); infection reports skew younger (median 57.5, range 35–82) and the 10 reports from China much younger (median 44, range 30–70).
- About 1 in 5 reports is a late filing. 51 reports (19%) say the complaint was found during a retrospective review and had never been reported to FDA. All 15 returned-device lab analyses this month belong to that group.
- South Korea is a distinct cluster: 30 reports (11%), 25 of them malfunctions, with short, formulaic narratives (hole in a cylinder, crack in the pump tubing).
- Tenacio pump: 35 reports carry the Tenacio brand, and the narratives of 6 more name a Tenacio pump. Recurring themes are self-inflation/deflation and a stiff, "gummy" or sticky pump, and swaps were reported in both directions (Tenacio→MS and MS→Tenacio).
The six categories group the reports for analysis; they are not an FDA MAUDE classification.
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Category n %
Malfunction 163 62% ████████████
Migration/placement 33 12% ██
Other 23 9% ██
Infection 22 8% ██
Dissatisfaction 14 5% █
Erosion/extrusion 10 4% █
Total: 265 reports173 of the 265 reports (65%) include a written description; the other 92 (35%) are codes only. Breakdowns that need the narrative, such as which part failed or what surgery followed, rely on those 173.
When problems surfaced, by category
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Under Yrs in place
Category 1 yr* Median Max
Malfunction 14 (9%) 5 19
Migration/placement 17 (52%) 0.5 8
Other 6 (26%) 1 9
Infection 11 (50%) 0 16
Dissatisfaction 4 (29%) 1 9
Erosion/extrusion 4 (40%) 3 21
* implanted in 2026, under a year oldMalfunctions typically surfaced years after implant (median 5 years, max 19); infections and placement problems cluster in the first year.
Device problem codes (all 265 reports)
Every report carries at least one MAUDE device problem code, about 2 on average, so the percentages add up to more than 100%. The 12 most frequent:
Code: Select all
Problem code n %
Inflation Problem 93 35% ████████████
Mechanical Problem 74 28% ██████████
Puncture/Hole 74 28% ██████████
Fluid/Blood Leak 71 27% █████████
Migration 32 12% ████
No Device Problem 32 12% ████
Collapse 29 11% ████
Air/Gas in Device 22 8% ███
Nonstandard Device 19 7% ██
Shape/Size 16 6% ██
Deflation Problem 13 5% ██
Malposition 8 3% █Some labels here and in the next chart are shortened from MAUDE's wording. "No Device Problem" stands for "Adverse Event Without Identified Device or Use Problem": something happened to the patient, but no device fault was named. Less common: Insufficient Device Problem Information (7); Degraded (6); Unintended Deflation and Human-Device Interface Problem (5 each); Connection Problem, Material Deformation, Failure to Deflate and Use of Device Problem (3 each); Infusion or Flow Problem, Audible Noise, Patient-Device Incompatibility and Manufacturing/Packaging/Shipping Problem (1 each).
Health effect codes
186 of the 265 reports (70%), including 149 of the 163 malfunctions, are coded "No Clinical Signs, Symptoms or Conditions". That means no injury beyond the device problem itself. It does not mean no surgery: nearly every described malfunction ended in another operation (2.2). 80 reports name an actual health effect, some more than one. The chart shows how many, with percentages of those 80:
Code: Select all
Health effect n %
Pain 23 29% ████████████
Infection 21 26% ███████████
Erosion 14 18% ███████
Tissue Injury 11 14% ██████
Discomfort 10 13% █████
Deformity 8 10% ████
Swelling/Edema 6 8% ███
Perforation 5 6% ███
Purulent Discharge 4 5% ██
Capsular Contracture 3 4% ██
Scar Tissue 3 4% ██
Hematoma 3 4% ██Less common: Adhesion(s), Erythema and Urinary Retention (2 each); Bacterial Infection, Fibrosis, Bleeding, Numbness, Impaired Healing and Hernia (1 each).
2. Malfunctions (163 reports)
2.1 Which part failed (the 96 malfunction reports with a description)
Code: Select all
Part named n %
Cylinder 27 28% ████████████
Pump 21 22% █████████
Tubing 17 18% ████████
Reservoir 4 4% ██
Connector 1 1% █
Not identified 26 27% ████████████- Cylinders: holes or ruptures in the left or right cylinder are the single most common finding. One patient heard a "pop" and both cylinders were found fractured near their base; others had holes through several layers, buckling cylinders or a bulge. In one bulge the outer layer had torn while the inner layer held, so fluid ballooned outward.
- Pump: bulb stays flat or won't rebound, pump stiff or hard to cycle, a faulty valve, and spontaneous inflation or deflation.
- Tubing: cracks or clean breaks where tubing meets the pump, cylinders or reservoir, plus a kinked reservoir line. Air was found in the pump in three of these tubing failures, and a CT scan showed air in a fourth. Five of the 17 tubing reports come from South Korea and describe a "crack" in the pump or cylinder connecting tube in near-identical wording.
- Reservoir: leak or hole traced to the reservoir; in one case a CT scan suggested reservoir fluid loss but bench testing found no hole.
- Connector: a connection found not fully seated.
- Not identified: 26 narratives say only "fluid loss" or "not inflating" without naming a source.
Code: Select all
Outcome n %
Full exchange 60 63% ████████████
Partial exchange 22 23% ████
Removed, not replaced 7 7% █
To a malleable 3 3% █
Revision pending 2 2% █
Returned device only 2 2% █A full exchange means the whole device was taken out and replaced; a partial exchange usually means the cylinders and/or pump were replaced and the original reservoir left in place. The 3 malleable conversions: one at the patient's request, one at the surgeon's request and one more switched to a Tactra.
2.3 How long the devices lasted
Device age is worked out from the implant and explant years only, so "0" means the same calendar year and "1" can mean anything from a few weeks to almost two years.
Code: Select all
Years in place n %
0 (same year) 12 9% ██
1 28 20% ██████
2-4 27 19% ██████
5-9 58 42% ████████████
10-14 9 6% ██
15+ 5 4% █
(139 of 163 have both years)- By 5 years, 50% of them had malfunctioned (median 5 years, max 19). 25% had failed by year 1, 75% by year 8 and 90% by year 10. These are shares of the 139 reported failures with both years given, not the odds that an AMS 700 fails by then: MAUDE has no count of the devices that are still working.
- Longest-lived: a 2007 implant (19 years), one from 2010 and three from 2011.
- Pump-related failures surfaced earliest (median 1 year, max 9; 15 dated reports), then tubing failures (median 4.5 years, max 10; 16 dated) and cylinder failures (median 6 years, max 19; 24 dated). The groups are small, so treat that as a hint rather than a finding.
Boston Scientific's lab examined 15 explanted devices this month (12 malfunctions, 2 infections, 1 placement report):
- The pump failed functional testing in 10 of 15, usually an "activation test". Specific defects included a deflation ball seated too far forward and a misaligned spring inside the pump. Three more pumps couldn't be tested because they contained body fluid, one passed, and the last was only leak-tested.
- Tubing worn down to its filament in 5 devices (four explicitly the kink-resistant tubing).
- Cylinder damage the lab did not put down to surgical instruments: holes at the corner of a fold, two fatigue holes in the inner tube, and a detached outer sleeve with broken fabric threads. Wear along fold lines was noted in 8 devices.
- Holes from sharp surgical instruments were found in 5 devices; in the one case where the lab commented, it put this down to damage most likely done during removal.
- Conclusions: 7 "cause traced to component failure" plus 4 where the lab says its findings "could have caused or contributed". That makes 11 of the 15 pointing at a component.
3. Infections (22 reports)
- Mostly early: 11 of 22 were 2026 implants, removed within months of going in, and three were 2025 implants, including a scrotal infection "several weeks" after surgery and one about ten months out. The longest gap was 16 years: the 2009 implant described below.
- Erosion-related infections: a cylinder eroding through the glans and urethral opening with pus (a 2009 implant), a cylinder eroded into the urethra (a 2021 implant), and erosion with infection in the distal corpora (implant year not given).
- Other details: a fungal scrotal infection, scrotal trauma at the pump site followed by bacterial growth, and infection after a later operation.
- Management (15 described): 8 removed with no replacement mentioned, 2 converted to a malleable, 2 bridged with a temporary Tactra and re-implanted with a new inflatable a few days later, 2 given a new inflatable in the same operation, 1 replaced with another manufacturer's device.
- Median patient age 57.5, range 35–82, against 68 (range 30–86) for all reports.
- Where: 5 involve the cylinders (through the penile shaft or corpora, impending distal erosion, protruding outside the corporal bodies), 3 the pump or scrotum, and 2 are unspecified.
- When: 4 were 2026 implants; the rest were long-standing (2005, 2013, 2021–2023, one not given).
- Notable fixes: smaller rear-tip extenders for an impending distal erosion (a 2005 implant); a cylinder that had crossed over to the other side, corrected with a new cylinder and pump; two converted to a Tactra.
- Reservoir (15 reports): reservoirs migrated or herniated out of their space into the pubic area or perineum, sometimes causing a bulge in the abdomen or pressure. 8 of the 15 are the low-profile Conceal reservoir and 3 the spherical one; 9 were 2026 implants. Two narratives point at patient factors: lifting something heavy against post-op restrictions and using the device too soon.
- Pump position (6 reports): a pump that rode high and became fixed in scar tissue after post-op bleeding, one too far back in the scrotum to reach, one needing longer tubing, and one riding so high that the tubing rubbed on the pubic bone.
- Cylinders (7 reports): crossover, cylinders migrating into the scrotum, proximal migration with loss of rigidity, and three floppy-glans / SST-type deformities: undersized cylinders on an MRI, cylinder tips that fell short of the glans, and (per the lab) a leaking cylinder.
- Timing: 17 of 33 were 2026 implants and another 10 went in during 2025; the longest gap from implant to removal was 8 years.
- Fixes were often partial: 11 of the 26 described revisions swapped only some components, 7 of them just the reservoir.
- Size and fit dominate: 7 are coded "Inadequacy of Device Shape and/or Size": too short (put down to a possible measuring error), oversized and hard to cycle, pump tubing too short to reach comfortably, and tubing so long it compressed the pump.
- Other reasons: not rigid enough, so the LGX was swapped for the stiffer CX; disliked the feel of the pump, with nothing found wrong; a stroke made pumping impossible and he asked for a malleable instead; removal requested because of age; and a cylinder bulge found during a dissatisfaction revision.
- Urethral injury or perforation (3): a cylinder into the urethra with urinary retention, the device judged too large and misplaced; a small urethral injury found at revision; and an injury during the implant operation itself, so a Tactra went in first.
- Damaged during unrelated surgery (2): a lumbar procedure damaged the reservoir, and another surgeon put a suture needle through the implant.
- Pain, with no malfunction described (6): scrotal, penile or abdominal pain leading to surgery; three were converted to malleable devices, and one patient had the device removed and chose no replacement.
- Selection or use issues (3): a 100 cc reservoir used where a 65 cc was intended and holding only 50 cc of saline; a patient who may have squeezed the inflate and deflate controls at the same time; and a pinhole in a cylinder that the surgeon put down to a suspected self-augmentation attempt.
- Miscellaneous (4): reservoir pressure in a man who also has an artificial urinary sphincter, a post-op hematoma that made the pump hard to find so it was repositioned, a reservoir with a hole swapped during surgery, and a punctured cylinder.
- No description (5): codes only; one is coded as a manufacturing/packaging problem.
8. Who appears in the reports
Age is given for 236 of 265 patients: median 68, range 30–86; half were between 61 and 74.
Code: Select all
Age group n %
Under 50 18 8% ██
50-59 31 13% ████
60-69 87 37% ████████████
70-79 74 31% ██████████
80 and over 26 11% ████Country. MAUDE uses FIPS-style country codes, so KS is South Korea (not Kansas), CH is China (not Switzerland), AS is Australia, SP Spain, SZ Switzerland, IS Israel and DR the Dominican Republic. The data itself confirms it: one KS report gives "SL" (presumably Seoul) as the state, while the two genuine Kansas reports are coded state KS, country US.
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Country n %
United States 203 77% ████████████
South Korea 30 11% ██
China 10 4% █
Canada 4 2% █
Spain 4 2% █
Australia 3 1% █
Egypt 3 1% █
Greece 2 1% █
Others, 1 each* 6 2% █
* Dominican Republic, Israel, Mexico,
Saudi Arabia, Switzerland and the UK- South Korea (30): 25 malfunctions; 12 are CXR cylinders; 15 carry exactly the same two codes (Mechanical Problem + Material Puncture/Hole), and most of its 18 narratives are short and formulaic ("went to the hospital… two weeks later… crack in the pump connecting tube"). That pattern suggests a single reporting channel rather than 30 independent observations.
- China (10): markedly younger patients (median 44, range 30–70); 6 of 10 are CXR.
- The narrow CXR cylinder is an Asia-heavy product here: 18 of the 27 CXR-branded reports come from Korea or China.
- United States (203): 38 states, led by Texas (25), Florida (19), California (17), Arizona (11), North Carolina and Ohio (10 each).
Code: Select all
Cylinder named n %
CX 82 31% ████████████
LGX 54 20% ████████
CXR 27 10% ████
Not named 84 32% ████████████
Reservoir only 18 7% ███
Pump named n %
MS 115 43% ████████████
Tenacio 35 13% ████
Not named 115 43% ████████████Among the 163 malfunctions alone: CX 46, LGX 36, CXR 18, cylinder not named 59, reservoir only 4; MS 72, Tenacio 19, pump not named 72. "Reservoir only" reports name just a reservoir (Conceal or spherical). 72 reports (27%) give only the generic name "AMS Inflatable Penile Prosthesis", and 50 narratives say the product details were never supplied to the manufacturer, which is why "not named" is such a large group.
9. How to read this (limitations)
- Counts, not rates. Without the number of devices implanted, 163 malfunction reports can't be turned into a failure rate or compared with other implants such as the Coloplast Titan.
- Reporting is uneven. Every report here was filed by the manufacturer; many events are never reported, and some are reported late (51 this month) or more than once.
- Missing detail. 35% of reports have no narrative and 72 don't name the model, so brand comparisons (CX vs LGX, MS vs Tenacio) inherit that gap.
- Years only. Implant and explant dates are given as years, so device ages are approximate (±1 year).
- Categories are an analysis grouping, not an FDA MAUDE classification, and some reports could fit more than one (erosion with infection, for example).
- Narratives contain obvious slips. One says "There were patient complications reported" where "no" was probably meant, and another swaps the model and lot numbers, so treat fine details with care.
- Lab results are a skewed sample: only 15 of 265 devices were analyzed, all from the late-filing group.
- If you have an AMS 700: the warning signs that recur in these narratives are loss of rigidity or fluid, a pump that stays flat or won't rebound, spontaneous inflation or deflation, a new bulge, and a pump or reservoir that has moved or become prominent. Those are worth raising with your urologist. A list of MAUDE reports is not, on its own, a reason to worry about a device that is working well.
