AMS 800 Artificial Urinary Sphincter 72404137Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878953003153), received between Apr 20, 2021 and Mar 26, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH ALL COMPONENTS WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 21699899 ↗
• InjurySep 12, 2023Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER WAS REMOVED DUE TO INCONTINENCE. THE DEVICE WAS NOT WORKING DUE TO FLUID LOSS FROM A HOLE IN THE BALLOON. A NEW ARTIFICIAL URINARY SPHINCTER WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 17733480 ↗
• InjuryJul 24, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER REMOVED DUE TO FLUID LOSS FROM A SMALL HOLE IN THE TUBING LEADING TO THE CUFF. A NEW ARTIFICIAL URINARY SPHINCTER WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376623 ↗
• InjuryApr 20, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER (AUS) REMOVED DUE TO INCONTINENCE AS A LARGE BIT OF EXTRA ISSUE WAS LEFT AROUND THE URETHRA AT THE TIME OF CUFF PLACEMENT, IN ORDER TO PROVIDE SOME PROTECTION TO A PREVIOUSLY DAMAGED URETHRA. THIS DOES NOT APPEAR TO HAVE BEEN EFFECTIVE THOUGH, AS URINARY INCONTINENCE WAS STILL BOTHERSOME. THE PATIENT HAD THE AUS CUFF REPLACED WITH A SMALLER CUFF.

  Patient problems: Urinary Incontinence

  MAUDE report 11697236 ↗

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-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-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-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