AMS Ambicor 72401456Recalls & reported problems
Boston Scientific Corporation · Inflatable Penile Prosthesis · Class 3 · Implant
All models of AMS Ambicor (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878953001005), received between Sep 2, 2021 and Jun 27, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Mechanical Problem2
- Deflation Problem1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT DID NOT BELIEVE THAT THIS AMBICOR PENILE PROSTHESIS (APP) WAS FUNCTIONING AS INTENDED AND REQUESTED A REPLACEMENT. RECORDS DO NOT INDICATE THAT A PROCEDURE HAS BEEN PERFORMED TO DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14835711 ↗InjurySep 2, 2021Deflation Problem; Inflation Problem; Mechanical Problem; Deflation Problem; Inflation Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLATION AND DEFLATION ISSUES WITH AN AMBICOR PENILE PROSTHESIS (APP). TROUBLESHOOTING WAS ATTEMPTED TO NO AVAIL. A REPLACEMENT SURGERY WAS PERFORMED IN WHICH THE EXISTING APP WAS REMOVED AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. NO AIR OR HOLES WERE OBSERVED IN THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12415218 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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