AMS 800 Artificial Urinary Sphincter 72404138Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878953003160), received between Dec 14, 2018 and Apr 8, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED MUSCLE ATROPHY AS A RESULT OF AN ARTIFICIAL URINARY SPHINCTER (AUS) GRACILIS FLAP PLACEMENT. THE CUFF WAS DOWNSIZED FROM 8 CM TO 4.5 CM TO RESTORE URINARY CONTINENCE. THERE WERE NO FURTHER COMPLICATIONS IN RELATION TO THIS EVENT.

  Patient problems: Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 11633521 ↗
• InjuryDec 1, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE PUMP. ALL ARTIFICIAL URINARY SPHINCTER (AUS) COMPONENTS WERE EXPLANTED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10927026 ↗
• MalfunctionDec 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING IMPLANT AN 8.0CM CUFF WAS TRIED NOT USED WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS CUFF WAS NOT IMPLANTED AND A NEW 7.0CM CUFF WAS IMPLANTED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8175277 ↗
• InjuryDec 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT EXPERIENCED RECURRING INCONTINENCE DUE TO ATROPHY WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS CUFF, PUMP, AND BALLOON WERE EXPLANTED AND A NEW 7.5CM AUS CUFF, PUMP AND BALLOON WERE IMPLANTED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Incontinence; Tissue Damage

  MAUDE report 8166947 ↗

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-0530-2025 · Oct 28, 2024 · Open, Classified
  AMS Artificial Urinary Sphincter Control Pump
• Z-0531-2025 · Oct 28, 2024 · Open, Classified
  AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
• 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