AMS 800 Artificial Urinary Sphincter 72404140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878953003177), received between Dec 21, 2022 and Aug 12, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 16, 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.

• InjuryAug 12, 2026Fluid/Blood Leak; Inadequacy of Device Shape and/or Size

  It was reported that this patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. A surgical procedure was performed during which the entire device was explanted and replaced. Upon explant the physician found fluid leakage in a way that could not make enough pressure to close the urethra. No additional information was provided.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50225838 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED RECURRING INCONTINENCE. THE CUFF WAS EXPLANTED, REPLACED, AND DOWNSIZED TO 7.5CM. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 21886511 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN CONTINENT FOLLOWING THE ARTIFICIAL URINARY SPHINCTER (AUS) SURGERY IN 2019. HOWEVER, THE PATIENT IS NOW EXPERIENCING BREAKTHROUGH LEAKAGE. PHYSICIAN STAYED THAT RETURN OF INCONTINENCE WAS LIKELY DUE TO ATROPHY AT BLADDER NECK URETHRA AND NOT RELATED TO DEVICE ISSUES. A NEW AUS WAS IMPLANTED. PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 17444512 ↗
• InjuryDec 21, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER 9 CM CUFF COMPONENT REPLACED WITH A 6.5 CM CUFF DUE TO INCONTINENCE AS THE CUFF WAS TOO LARGE. THE CUFF WAS THE CORRECT SIZE AT THE TIME OF THE INITIAL IMPLANT ACCORDING TO THE PHYSICIAN MEASURED. THE PATIENT WAS STILL LEAKING UPON ACTIVATION OF HIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 16023169 ↗

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