Genesis (Coloplast), Tactra (Boston Scientific) and Rigi10 (Rigicon)
A breakdown of the FDA MAUDE adverse event reports on the Genesis, Tactra and Rigi10 malleable implants covering September 1–30, 2026. There are 11 reports in all: 2 Genesis, 9 Tactra and none for Rigi10. Report numbers are left out, and cases are identified by location and, where reported, age instead.
TL;DR
- Rod position is the main story. Five reports give an actual reason for surgery, and four of them involve where the rod ended up: too close to the skin, crossed over, migrated, or coded as malpositioned.
- Only one report records an actual erosion. It was a Tactra in an 84-year-old, roughly four years after implant. The Genesis report listed under erosion was a near-miss, caught before the rod broke through.
- Both Genesis implants came out within months because of placement problems. Coloplast's records review found both lots in spec.
- Tactra's 9 is not a clean monthly count. Three are late filings that Boston Scientific found in a retrospective review of complaints that should have been reported to FDA earlier, and one of those events dates to 2025. Most Tactra reports also contain little or no detail.
- None of the 11 reports includes a manufacturer's analysis of the device, so no root cause was confirmed.
- These reports can't tell you how often problems happen. See "How to read these numbers" below.
At a glance (all 11 reports)
- With a published narrative: 6
- US / non-US country codes: 4 / 7
- Rod-position problem coded ("Malposition of Device" or "Migration"): 4
- Patient harm coded (anything other than "No Clinical Signs, Symptoms or Conditions"): 3
- Implanted and removed in the same year: 3
- Flagged as late-filed: 3
- Device analysis reported: 0
Genesis (Coloplast): 2 reports
Both reports have a narrative and both are coded Malposition of Device with no clinical harm. In both cases the implant went in and came out in 2026.
1) AU (Austria under FIPS, Australia under ISO), age not reported, listed under Erosion/Extrusion
- What happened: The rod was found sitting very superficially, just under the skin, and showing toward the tip of the penis. The surgeon judged it at risk of eroding through the skin and replaced it with a Rigicon malleable.
- Manufacturer response: The device was not returned. Coloplast accepted the surgeon's observation as the reason for surgery. Manufacturing records showed the lot met all specifications, and there was no complaint trend for the lot.
- Comment: This was an impending erosion, not an actual one. The rod came out before it broke through, which likely explains the "no clinical signs" code despite the erosion category. The patient stayed with a malleable but switched brands, and the report doesn't say why.
2) Ohio, age 69, listed under Herniation/Migration/Placement
- What happened: The Genesis was removed because of crossover and replaced with an inflatable (IPP). No damage was seen on the removed device.
- Manufacturer response: The device was not returned. The lot met specifications, with no complaint trends, nonconformances or corrective actions (CAPAs) linked to it. Coloplast says it can't comment on the device's condition without examining it and will file a follow-up if more information arrives.
- Comment: Crossover means a rod has passed through the septum, the wall between the two erection chambers, into the opposite chamber. It typically happens during dilation, when the chambers are opened up to take the rods. That makes it a placement complication rather than a defect in the rod, which fits "no damage noted." The report doesn't say whether going to an inflatable was the patient's choice or the surgeon's.
Genesis takeaway: These are two early, placement-related removals with no sign of a device defect, and each report says what went wrong and what the patient got instead.
Tactra (Boston Scientific): 9 reports
Only 4 of the 9 have a narrative, and none of those four is among the reports that record patient harm. The reports fall into two clear groups.
Group A: three US reports with patient harm coded and no narrative
- Florida, age 84, implanted 2022, removed 2026 (~4 years), listed under Erosion/Extrusion. Problem: Migration. Health effects: Erosion, Pain, Scar Tissue. This is the only report this month that records an actual erosion, and he is the oldest patient in the set.
- Arizona, age 71, implanted 2024, removed 2026 (~2 years), listed under Herniation/Migration/Placement. Problem: Malposition of Device. Health effect: Unspecified Tissue Injury.
- Texas, age 69, implanted 2020, removed 2026 (~6 years), listed under Patient Dissatisfaction. Problem: Patient-Device Incompatibility, the reporting term for a problem in how the device interacts with the patient's body. Health effect: Discomfort.
Group B: six reports listed under "Other", all with non-US country codes
- Brazil, age 55, removed 2026. Insufficient information and no narrative.
- AS (Australia under FIPS, American Samoa under ISO), age 63, implanted and removed 2026. Coded Nonstandard Device, which is an unusual code. With no narrative, there's no telling what was non-standard. This is the only Tactra known to have come out in the same year it went in.
- Brazil, age 57, removed 2026. Replacement surgery for unspecified reasons, with no complications reported.
- UK, age not reported, removed 2026. Revision for unspecified reasons, with part of the device still implanted. The report doesn't say whether one rod was deliberately left in or a fragment remained.
- Ecuador, with no age, implant year or removal year. "Tactra surgery" for unspecified reasons. It isn't even clear this was a revision. Also coded Adverse Event Without Identified Device or Use Problem.
- Italy, age and implant year not reported, removed 2025. Unspecified reason, and the Tactra was replaced with an inflatable. This is the only Tactra report with a full investigation summary, which concluded "no problem detected." Its findings:
- the device was unavailable;
- the lot number was unknown, so there was no manufacturing-record review;
- there was no sign of misuse or off-label use;
- reoperation is a documented risk in the product's risk file.
The late-filing issue
Three of the Group B narratives (UK, Ecuador, Italy) carry the same disclosure:
- the event turned up during a retrospective review of complaint events;
- a report should have gone to FDA earlier but didn't;
- Boston Scientific has opened an internal nonconformance investigation into why its reporting process missed it.
- September's Tactra count includes backlog. The Italy case came out in 2025, while manufacturers normally have 30 calendar days from learning of a reportable event to file it.
- Earlier months' Tactra numbers may have been undercounted. If the review is still running, more back-filed reports could appear in coming months and inflate those counts without any new events behind them.
- This is a reporting-process problem that Boston Scientific disclosed itself. On its own, it says nothing about how safe the device is.
Rigi10 (Rigicon): 0 reports
No Rigi10 reports appeared this month. As with the other counts, that on its own says nothing about how often problems happen (see "How to read these numbers" below).
Patterns across all 11 reports
- Position, position, position. The reports include a superficial rod, a crossover, a migration with erosion and a malposition with tissue injury. Malleables never soften, so the rods press constantly on the tissue at the end of the penis. That's why sizing and placement matter so much with this type of implant, and why rods migrating toward the tip and eroding are recognized risks.
- Two timelines. Three implants came out in the same year they went in, and three came out 2–6 years later. The early ones with narratives were placement problems, while the late ones involve migration, erosion and discomfort. The numbers are tiny, but that matches how implant complications are usually grouped: early problems tend to be surgical, and later ones tend to be about tissue and fit.
- What came next. Where the follow-up surgery is described, two men went from a malleable to an inflatable (Ohio and Italy), and one switched to a Rigicon malleable (AU). For the rest, it's unknown.
- "No clinical signs" doesn't mean nothing happened. Eight of the 11 reports are coded that way, yet every report involves surgery, and at least 10 of the 11 involve removing or revising the implant. That surgery is usually what makes these events reportable in the first place.
- No device analysis. The three reports that mention it say the device wasn't returned or wasn't available, and the rest are silent. The only word on the hardware itself is the Ohio report's note that the removed Genesis showed no damage. The "met specifications" and "no problem detected" conclusions come from paperwork reviews of lot records, complaint trends and labeling. They can neither confirm nor rule out a device problem.
- Notably absent: nothing is coded as infection or mechanical breakage. With six reports giving no reason at all, though, neither can be ruled out.
- Ages: where reported (7 of 11), patients were 55 to 84, with a median of 69. The three US Tactra reports with harm coded involved men aged 69, 71 and 84.
How to read these numbers
- No denominators. We don't know how many of these implants were placed, so report counts say nothing about complication rates.
- One month, 11 reports. That's far too few to separate signal from noise.
- MAUDE's built-in limits. Reports are unverified and often incomplete, they can be duplicated, and they don't establish that the device caused the event. Manufacturers also have to report events abroad involving devices like those sold in the US, which is why so many countries appear.
Bottom line
September's malleable reports point at rod position: superficial placement, crossover, migration and the erosion it can lead to. Nothing in them points to broken rods or manufacturing defects.
Many of the reports are thin on detail, and three are late filings from a reporting lapse Boston Scientific is now investigating.
For anyone weighing a malleable, rod sizing, placement and how the tissue holds up over the years are worth discussing with your surgeon.
Glossary
- Crossover: a rod passing through the septum into the opposite erection chamber.
- Erosion / extrusion: an implant wearing through tissue (skin, glans or urethra).
- Revision / explant: follow-up surgery to fix, replace or remove an implant.
- MAUDE: the FDA's public database of medical device adverse event reports.
- Lot / device history record: the production batch a device came from, and the manufacturing paperwork showing it passed inspection.
- CAPA / nonconformance: a manufacturer's formal processes for tracking and correcting quality problems.
Source: FDA MAUDE adverse event reports for Genesis, Tactra and Rigi10 malleable penile prostheses, September 1–30, 2026. MAUDE data are unverified and can't be used to calculate complication rates or show that a device caused an event.
