AMS 800 Artificial Urinary Sphincter 72400166Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00878953000770), received between Oct 20, 2020 and Apr 1, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. UPON REVISION, IT WAS NOTED THAT THE CUFF SIZE WAS TOO LARGE. AS A RESULT, THE CUFF WAS EXPLANTED, DOWNSIZED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Urinary Incontinence

  MAUDE report 24753982 ↗
• InjuryOct 30, 2025Mechanical Problem; Nonstandard Device; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTED ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT URINARY INCONTINENCE. IT WAS ALSO NOTED THAT THE DEVICE WAS NOT FUNCTIONING. AS A RESULT, THE AUS WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23431681 ↗
• InjuryAug 27, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) DEVELOPED A CHRONIC SUBCLINICAL INFECTION, WHICH LED TO URETHRAL EROSION AND MIGRATION OF THE CUFF INTO THE URETHRAL LUMEN. THE AUS WAS EXPLANTED WITHOUT REPLACEMENT, AND A HEALING PERIOD WAS INDICATED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22902675 ↗
• InjuryJun 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED RECURRING INCONTINENCE DUE TO DUE TO SPHINCTER INSUFFICIENCY. THE AUS WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22285475 ↗
• InjuryApr 9, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT AN ARTIFICIAL URINARY SPHINCTER (AUS) WAS IMPLANTED IN (B)(6) 2023 AND THEN, THE PATIENT PRESENTED A QUICK RELAPSE OF INCONTINENCE DUE TO A MECHANICAL FAILURE. AFTER A MEDICAL ANALYSIS, A SURGICAL PROCEDURE WAS PERFORMED AND DURING THIS, IT WAS NOTICED THAT THE AUS CUFF WAS PERFORATED ON ONE OF THE FOLDS, WHICH RESULTED IN THE REMOVAL AND THE REPLACEMENT OF THE CUFF. THE PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN.

  Patient problems: Incontinence; Urinary Incontinence

  MAUDE report 21809122 ↗
• InjuryFeb 11, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENTS ARTIFICIAL URINARY SPHINCTER DEVICE MALFUNCTIONED RESULTING IN THE PATIENT EXPERIENCING RECURRING INCONTINENCE. EXAMINATION BY THE PHYSICIAN IDENTIFIED THE URETHRA WAS INTACT. THE AUS CUFF AND BALLOON WERE EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 21360879 ↗
• InjuryMar 22, 2023Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) REVISION SURGERY DUE TO INCONTINENCE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 16595134 ↗
• InjuryOct 31, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) SINCE THE DEVICE STOPPED WORKING PROPERLY. A SURGERY WAS PERFORMED AND THE DEVICE WAS REMOVED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 15699904 ↗
• InjuryFeb 28, 2022Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER REMOVED DUE TO LEAKS FOR THE PAST FEW MONTHS. THE DEVICE MALFUNCTION WAS CONFIRMED UNDER X-RAY. A NEW ARTIFICIAL URINARY SPHINCTER CONSISTING OF A CUFF, PUMP, AND BALLOON WAS IMPLANTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624735 ↗
• InjuryMay 17, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REVISE AN ARTIFICIAL URINARY SPHINCTER (AUS) SURGERY DUE TO A MALFUNCTION OF THE CUFF. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. THE CUFF WAS PIERCED WHEN EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 11838587 ↗
• InjuryOct 20, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REPLACEMENT OF AN ARTIFICIAL URINARY SPHINCTER(AUS) DUE TO A MALFUNCTIONING CUFF. AN X-RAY SHOWED AN EMPTY CUFF IN BOTH OPEN AND CLOSED POSITIONS. WHEN THE CUFF WAS EXPLANTED, IT WAS PERFORATED AND HAD HOLES. THE PATIENT WAS EXPERIENCING CYSTITIS AND URINE LEAKAGE WHEN STANDING AND COUGHING.

  Patient problems: Incontinence; Inflammation; Unspecified Infection

  MAUDE report 10705876 ↗

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-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