AMS Ambicor 72401457Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00878953001012), received between Oct 21, 2019 and Aug 3, 2026 — classified as 6 injuries.

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Degraded; Mechanical Problem

  It was reported that this Ambicor Penile Prosthesis (APP) was not working properly. Upon inspection, an aneurysm of the cylinder was identified, and fluid was not returning to the reservoir as expected. As a result, the device was explanted and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123743 ↗
• InjuryNov 19, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS WAS NO LONGER PERFORMING AS EXPECTED, IT HAD INFLATION ISSUES. THE PATIENT UNDERWENT SURGERY TO REPLACE THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725471 ↗
• InjuryOct 14, 2021Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS AMBICOR PENILE PROSTHESIS (APP). THE PHYSICIAN NOTED THERE WAS A HOLE IN THE LEFT CYLINDER, WHICH IS CONSISTENT WITH WEAR. THE APP WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS SET TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12635787 ↗
• InjuryDec 23, 2019Break; Break

  IT WAS REPORTED THAT THE AMBICOR PENILE PROSTHESIS (APP) DEVICE WAS EXPLANTED BECAUSE THE PROSTHESIS BROKE. A NEW 20CM X 15.5 MM APP DEVICE WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9514248 ↗
• InjuryNov 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AMBICOR PENILE PROSTHESIS (APP) SURGERY DUE TO THERE WAS A LEAK IN THE RIGHT CYLINDER. THE APP DEVICE WAS REPLACED WITH A NEW 15.5 MM APP. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO HIS EVENT. NO MORE INFORMATION IS AVAILABLE AT THE MOMENT, ADDITIONAL INFORMATION WILL BE PROVIDED AS RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9289608 ↗
• InjuryOct 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION WITH AN AMBICOR PENILE PROSTHESIS (APP). A SURGICAL PROCEDURE WAS PREVIOUSLY PERFORMED ON AN UNKNOWN DATE IN WHICH ALL THE COMPONENTS WERE REMOVED. THE PATIENT DID NOT EXPERIENCE ANY FURTHER COMPLICATIONS WITH THIS PROCEDURE. A REIMPLANT SURGERY WAS PERFORMED IN WHICH A NEW TACTRA PENILE PROSTHESIS WAS IMPLANTED. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT'S OUTCOME. NO MORE INFORMATION AVAILABLE AT THE MOMENT, FURTHER INFORMATION WAS REQUESTED. NO MORE INFORMATION AVAILABLE AT THE MOMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 9215435 ↗