AMS Ambicor 72401458Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878953001029), received between Sep 24, 2019 and Jan 5, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Deflation 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Deflation Problem; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN AMBICOR PENILE PROSTHESIS (APP) PRESENTED FOR A FOLLOW UP APPOINTMENT IN 2025, DURING WHICH A PUMPING ISSUE WAS IDENTIFIED. THE LEFT CYLINDER FAILED TO DEFLATE AND REMAINED INFLATED IN THE RESTING POSITION. A REVISION SURGERY WAS PERFORMED IN WHICH THE DEVICE WAS REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970647 ↗
• InjuryJul 21, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) STOPPED INFLATING. THE APP WAS EXPLANTED AND REPLACED WITH TACTRA AND INFLATABLE PENILE PROSTHESIS (IPP). THE IPP WAS PLACED ON THE LEFT SIDE WITH THE RIGHT CYLINDER REMOVED AND PLUGGED. AND A MALLEABLE WAS PLACED ON THE LEFT DUE TO THE DISPARITY IN PROXIMAL MEASUREMENTS. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561573 ↗
• MalfunctionNov 15, 2023Deflation Problem; Inflation Problem; Mechanical Problem; Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) EXPERIENCED INFLATION AND DEFLATION ISSUES. THE PATIENT STATED THAT THE DEVICE HAS NOT WORKED SINCE THE IMPLANT PROCEDURE AS IT HAS ALWAYS REMAINED ONE-THIRD INFLATED. THE PHYSICIAN SUGGESTED HIM TO REMOVE THE APP; HOWEVER, NO SURGERY HAS BEEN PERFORMED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139373 ↗
• InjuryFeb 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS AMBICOR PENILE PROSTHESIS (APP) DEVICE DUE TO INFECTION SECONDARY TO EROSION OF THE VENTRAL GLANS OF THE PENIS. IT WAS NOTED ONLY ONE CYLINDER WAS IMPLANTED AS THE PATIENT IS TRANSGENDER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 11323911 ↗
• InjurySep 24, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THIS AMBICOR PENILE PROSTHESIS (APP) DUE TO SENSITIVITY CAUSING THE PUMP TO BE TOO PAINFUL FOR THE PATIENT TO OPERATE. THE APP WAS REMOVED AND REPLACED WITH A MALLEABLE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS. PRODUCT RETURN IS NOT EXPECTED, BUT SHOULD FURTHER INFORMATION BECOME AVAILABLE, BSC WILL SUBMIT A SUPPLEMENTAL REPORT WITH ANY NEW INFORMATION.

  Patient problems: Pain

  MAUDE report 9111025 ↗