Device class: Malleable penile prosthesis, multiple brands | Period: July 2026 | Pulled: 2026-08-06
Total reports: 13 (Jul 1 – Jul 31, 2026)
Summary of Reported Adverse Events: All 13 reports
- Tactra (Boston Scientific): 12 events
- No reason given beyond "unspecified" was much the largest group this month (8 of 12): explant, replacement, or revision procedures whose narratives say only that the device was removed and, in most cases, replaced with an inflatable prosthesis, with no cause recorded. Implant-to-event duration is on record for four of these (implanted 2025 and explanted 2026; implanted 2024 and explanted 2026; and two implanted and explanted within 2026), and is not on record for the other four.
- One explant with no device issue stated: the report says plainly that the device was explanted and replaced with a three-piece inflatable prosthesis and that there were no device issues.
- One confirmed mechanical malfunction: a device that ruptured during the implant surgery itself, in a patient who had developed fibrosis from previous surgeries; the procedure was completed with a new device.
- One extrusion: the device extruded and was removed surgically.
- One infection: a patient with a Tactra developed an infection and the device was removed surgically, with no organism or symptom detail beyond the word "infection."
- Full breakdown by cause (12 total): no reason given beyond "unspecified" (8); explant with no device issue stated (1); confirmed mechanical malfunction (1); extrusion (1); infection (1).
- Genesis (Coloplast): 1 event
- One clinical complication with no established cause: persistent perineal pain, obstructive voiding symptoms, and suspected urethral obstruction following implantation, with a revision and cystoscopic reassessment recommended. The device was implanted in 2025 and had not been explanted at the time of the report.
- Zero mechanical malfunctions, infections, or dissatisfaction cases were reported for Genesis this month.
Data Source
FDA's public MAUDE database
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. The incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information. Submission of a medical device report and the FDA's release of that information is not necessarily an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.
