AMS 800 Artificial Urinary Sphincter 72400167Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00878953000787), received between Mar 5, 2019 and Nov 21, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (5 reports).

6 other recalls cover devices cleared under the same FDA submission (P000053); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING AN ARTIFICIAL URINARY SPHINCTER (AUS), A BLACK FRAGMENT WAS IDENTIFIED WHILE FILLING THE CUFF. THE CUFF WAS REPLACED, AND NO ADVERSE CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622883 ↗
• InjuryDec 13, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED RECURRING INCONTINENCE DUE TO THE DEVICE WAS NOT PERFORMING AS EXPECTED. AFTER REMOVAL OF THE DEVICE IT WAS OBSERVED THAT THE CUFF WAS PUNCTURED. THE AUS WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 20926453 ↗
• InjuryMar 20, 2024Mechanical Problem; Decrease in Pressure; Mechanical Problem; Decrease in Pressure

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER WAS REMOVED DUE TO A TECHNICAL DEFICIENCY WITH REDUCTION IN BALLOON VOLUME AND LOSS OF EFFECTIVENESS INDICATING PATIENT INCONTINENCE. A NEW ARTIFICIAL URINARY SPHINCTER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 18945781 ↗
• InjuryFeb 13, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER EXPERIENCED RECURRING INCONTINENCE AS THE DEVICE WAS NOT WORKING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACED ALL THE COMPONENTS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 18699824 ↗
• InjuryFeb 13, 2023Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS EXPERIENCING REAPPEARANCE OF URINARY INCONTINENCE. AN X-RAY CONFIRMED THAT THE SYSTEM WAS DRAINED AND THERE WAS A HOLE IN THE CUFF. A REPLACEMENT SURGERY WAS PERFORMED IN WHICH ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 16368619 ↗
• InjuryApr 22, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MECHANICAL DYSFUNCTION WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS CUFF, PUMP, AND BALLOON WAS EXPLANTED AND A NEW AUS CUFF, PUMP, AND BALLOON WAS EXPLANTED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8537832 ↗
• InjuryMar 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS CUFF, PUMP, AND BALLOON WAS EXPLANTED AND A NEW AUS CUFF, PUMP, AND BALLOON WAS IMPLANTED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS.

  Patient problems: Incontinence

  MAUDE report 8416719 ↗
• InjuryMar 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DUE TO DEVICE NO LONGER FUNCTIONING THE PATIENT HAD HIS ARTIFICIAL URINARY SPHINCTER (AUS) REMOVED AND REPLACED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8391525 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000053. One submission often covers many models, so check the product and lot details in each record.

• Z-0531-2025 · Oct 28, 2024 · Open, Classified
  AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
• Z-0530-2025 · Oct 28, 2024 · Open, Classified
  AMS Artificial Urinary Sphincter Control Pump
• Z-2442-2019 · Jul 19, 2019 · Terminated
  AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
• Z-1280-2013 · Mar 1, 2013 · Terminated
  AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) followi
• Z-1279-2013 · Mar 1, 2013 · Terminated
  AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) follow
• Z-2669-2011 · May 9, 2011 · Terminated
  AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, M