October 2026: FDA Malleable Adverse Events Summary

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October 2026: FDA Malleable Adverse Events Summary
Tactra (Boston Scientific) · Genesis (Coloplast) · Rigi10 (Rigicon)

19 adverse event reports for malleable (bendable-rod) penile implants in the FDA's MAUDE database for October 1–31, 2026: what they show, what they don't, and how to read them. Tools Used: High Speed Internet, Google, Claude and Notepad.

Before you read the numbers

• A report is not proof the implant failed. MAUDE collects reports of suspected device problems, and the FDA itself says the data can't be used to work out how often problems happen, to track changes over time, or to compare devices.
• There's no denominator. MAUDE doesn't include how many of each implant were put in, so none of this converts into failure rates or a brand ranking.
• Companies report differently. Boston Scientific appears to file a report even when all it knows is that a Tactra was taken out or replaced. Five of its 15 reports this month give neither a reason for the surgery nor any product details.
• "October" is when the reports came in, not when the problems happened. Some events go back to 2023.

1. At a glance

• Tactra (Boston Scientific): 15, all filed by Boston Scientific
• Genesis (Coloplast): 3, 1 filed by Coloplast, 2 forwarded
• Rigi10 (Rigicon): 1, forwarded
• Total: 19, 16 filed by the maker, 3 forwarded

Forwarded means a different company passed the information to the FDA (see section 4).

2. Key takeaways

• No report describes a broken rod, but that's not the same as "no rods broke". 9 of the 19 reports don't say why the surgery happened at all. The one bending problem was put down to sizing and fixed with a larger rod.
• Sizing was the most common identifiable Tactra problem: 3 reports. Two implants were too small and one was too big. All three needed another operation.
• Infection: 3 reports. Two Tactra (one about four years after implant, one within months) and one Genesis.
• Erosion: 1. Migration/protrusion: 1 patient. Both Tactra. The migration case was filed as two reports, apparently one per rod.
• Tactra problems that can be dated mostly showed up early, in the implant year or the year after.
• Three Tactra patients switched to an inflatable (IPP).
• Some of this is old news. Two Tactra reports describe events from 2023 and 2024.
• Three of the four non-Tactra reports appear to have come from Boston Scientific, probably because a Boston Scientific implant replaced the competitor's device.

3. Tactra (Boston Scientific): 15 reports
All 15 were filed by Boston Scientific itself. Two are very likely the same patient, so this is about 14 men.

Why the surgery happened

• 5 no reason given (and no product details)
• 3 sizing: 2 too small, 1 too big
• 2 infection
• 2 migration/protrusion (1 patient)*
• 1 erosion
• 1 discomfort linked to how the incisions were closed
• 1 patient dissatisfaction

* One of this patient's two reports gives no reason on its own. It's counted here because it matches the other on lot, dates, age and country.

Sizing (3 reports)
Two implants were too small and one was too large, and all three meant another operation. One undersized implant (India) had a bending problem that a workaround didn't fix, so it was swapped for a larger size. The other was re-measured and replaced.

The oversized one (Arizona) left an S-shaped curve the patient was unhappy with, and he switched to an inflatable. Those were already the narrowest Tactra rods, and an S-curve usually points to rods that are too long, so length was most likely the issue. Tactra rods are trimmed to length during surgery, so this comes down to the surgeon's measurement.

Infection (2 reports)
One was late, about four years after implant, and only the infected side was taken out; nothing says what became of the other rod.

The other came within months of a 2026 implant. Antibiotics came first; at surgery the surgeon found infection plus a crossover, a perforation running from the left side to the right, which was filed as migration. The implant was taken out and replaced in the same operation (a salvage).

Erosion and migration
The one erosion, on one side, came about three years after implant, and that man switched to an inflatable. The one migration case (Brazil, filed as two reports) began within months of a 2026 implant: one rod had already been removed and the other was poking through the tissue, with replacement surgery planned.

Everything else
One revision was for discomfort the surgeon linked to how the incisions were closed at the first operation; the implant was replaced and the incisions closed a different way. One man switched to an inflatable because he was dissatisfied, with no detail on why.

The five reports with no reason and no product details only confirm that a revision happened. In three of them a new Tactra went in, which is presumably how Boston Scientific heard about it, and in one the device that came out may not even have been a Tactra.

What happened next

• 3 swapped for a new Tactra
• 5 replaced, new device type not stated
• 3 switched to an inflatable (IPP)
• 3 only one rod removed
• 1 surgery mentioned, outcome not described

Timing
For the 9 reports that give an implant year (the other 6 don't), here are the years from implant to the event date and to the year the implant came out:

• Same calendar year: 4 by event date, 3 by removal year
• Following year: 3 by event date, 3 by removal year
• 3 years later: 1 by event date, 2 by removal year
• 4 years later: 1 by event date, 1 by removal year

The two measures differ because the event date isn't used consistently. In 8 of these 9 reports it falls in the year the implant came out, but for the S-curve case it's 2023 while the rods came out in 2026. Either way, most problems that can be dated were early, which points to surgery and fit rather than rods wearing out, though nine reports is a small sample.

How the FDA coded them
Most reports use the FDA's catch-all codes: 8 of 15 say there isn't enough information to name a device problem, and 3 say no device or use problem was found. The rest point to size (3) or migration (2).

9 of 15 are coded as having no clinical signs or symptoms, yet every one of those men had surgery, so that code means no specific injury was reported, not that nothing happened.

Sizes, lots, places, ages

• Diameters (by report): 9.5 mm ×3, 11 mm ×3, 13 mm ×3 (two of those are the same patient), unknown ×6.
• Lots: 9 reports give a lot number, covering 8 different lots made between September 2021 and July 2025. The only repeat is the same-patient pair. No sign of a bad batch in this month's reports.
• Where: USA 7 (one each from AZ, CA, FL, KY, NC, OH, WV), Brazil 4 (probably 3 patients), and one each from India, Canada, an unclear country code and an unreported country.
• Ages: given for 11 men: 55 to 78, median 70.

Gap between event and report
The median gap is 28 days, and 12 of 15 reports are dated within 60 days of the event. The three outliers are the S-curve case (about 3 years 4 months), the India sizing case (about 2 years 8 months) and the erosion (about 10 months, from an estimated date).

A manufacturer must report within 30 days of becoming aware of an event (21 CFR 803.50), so long gaps don't by themselves mean late filing.

4. Genesis (Coloplast): 3 reports
Only one was filed by Coloplast itself: a Genesis taken out and replaced because of infection, in California. With no lot number, Coloplast says it couldn't check its manufacturing and complaint records, and it never got the device back to examine.

The other two are forwarded reports with almost no detail: no location, age or dates. Both describe a malleable being replaced for no stated reason, in one case with a new Tactra. One refers to the removed implant only as another company's malleable, which is how Boston Scientific would put it.

What "forwarded" means: when a company gets adverse-event information about a device it didn't make, it doesn't file its own report. FDA rules (21 CFR 803.22(b)(2)) tell it to send the information to the FDA with a cover letter saying the device isn't theirs, and the FDA posts it with a note saying so. All three forwarded reports this month carry that note.

5. Rigi10 (Rigicon): 1 report
A single forwarded report with no location, age or dates: surgery on a Rigicon implant for no stated reason, after which an inflatable was put in. It's worded the way Boston Scientific words its own reports. Oddly, its brand field names the replacement (an inflatable) rather than the Rigi10 that came out.

6. Comparing brands fairly
It's tempting to read 15 vs 3 vs 1 as "Tactra has five times the problems". The data can't support that:

• Reporting habits differ. Take out the five Tactra reports that say nothing beyond "a revision happened" and Tactra has 10 reports (9 men) that give a reason.
• Who reported what. Rigicon filed no Rigi10 report of its own in this batch and Coloplast filed one Genesis report. The other three competitor reports appear to have come via Boston Scientific.
• No denominators. A brand with more implants in place will generate more reports even if it's just as reliable, and MAUDE has no implant counts to adjust for that.
• Small numbers. One month, 19 reports. One country's or one surgeon's reporting can swing it; Brazil alone accounts for 4 of the Tactra reports.

What the reports do show is the kind of trouble: infection, erosion, a migrating rod and sizing, familiar risks of penile implant surgery in general. Nothing in the reports that give details points to a new or brand-specific failure, but nearly half give no details at all.

7. Data quirks

• Unclear country: one report uses the country code for Eswatini. It may be right, or a slip for Switzerland.
• "CA" means two things: as a country it's Canada (one report), as a state it's California (another).
• Old report dates: all three forwarded reports are dated April 30, 2026 but only showed up in the October batch.
• Estimated date: the erosion report's event date is a placeholder, as the manufacturer notes.
• Inconsistent coding: the two reports for the same Brazil patient are coded differently, one as migration with perforation, the other as not enough information and no symptoms.
• Redactions: two forwarded reports black out the device name in the text under a privacy exemption, even though another field names it.
• Product name and model: the six Tactra reports without product data use a different, misspelled product name and an "unknown" model code.
• Event date isn't used consistently (see Timing in section 3).

8. Glossary

• Malleable implant: two bendable rods inside the penis that you position by hand. No pump, no fluid.
• IPP: inflatable penile prosthesis. Fluid-filled cylinders with a pump in the scrotum.
• Revision: a later operation to remove and/or replace an implant.
• Erosion: part of the implant wears through the surrounding tissue.
• Migration / crossover / perforation: a rod moves out of place, crosses into the other erectile chamber, or pushes through tissue.
• Salvage: removing an infected implant, washing out the space and putting in a new implant in the same operation.
• S-curve deformity: an S-shaped bend, typically from rods too long for the space.

9. Bottom line
Where October's malleable reports give a reason, it's about the operation and the fit (sizing, infection, one migrating rod, one erosion), mostly in the implant year or the year after. None describes a rod wearing out or breaking, though nearly half give no reason at all.

If you're weighing a malleable, those are fair things to raise with a surgeon: how they measure and size, what they do to prevent infection, and their experience with revisions.

Not medical advice, just a reading of public FDA data. Corrections welcome.

Sources: FDA MAUDE database and the FDA's "About MAUDE" page; 21 CFR 803.22 and 803.50