AMS 800 Artificial Urinary Sphincter 72404144Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878953003191), received between May 25, 2022 and Sep 21, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this patient with an Artificial Urinary Sphincter (AUS) experienced pelvic trauma. During a clinic visit a cystoscopy procedure was performed during which it was discovered that there was erosion at the bulbous urethra, and a surgical procedure was performed in (b)(6) 2026, during which the cuff was explanted. An infection was confirmed later on which resulted in another surgical procedure in (b)(6) 2026, during which the pump and Pressure Regulating Balloon (PRB) were explanted. The physician was unable to identify the type of infection the patient had. The infection was treated with antibiotics. There were no device issues, the patient fully recovered, and there was no additional information was provided.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50843404 ↗
• InjuryMay 25, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO HAVE AN ARTIFICIAL URINARY SPHINCTER (AUS) CUFF EXPLANTED AND A NEW SMALLER AUS CUFF IMPLANTED DUE TO RECURRING INCONTINENCE. THE PHYSICIAN BELIEVED THAT A SMALLER CUFF SIZE WOULD RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 14502217 ↗

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