AMS 800 Artificial Urinary Sphincter 72400165Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00878953000763), received between Mar 12, 2019 and Sep 18, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 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 WITH ACUTE URINARY RETENTION ACCOMPANIED BY PELVIC PAIN. LABORATORY TESTS REVEALED AN INFLAMMATORY SYNDROME, AND AN ABDOMINOPELVIC COMPUTED TOMOGRAPHY SCAN SHOWED FINDINGS SUGGESTIVE OF AN INFECTION. THE AUS WAS EXPLANTED, AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Abdominal Pain; Inflammation; Unspecified Infection; Urinary Retention

  MAUDE report 23092118 ↗
• InjuryAug 8, 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 CATHETERIZATION DIFFICULTIES, REQUIRING A RE-EVALUATION OF THE TECHNIQUE. A CYSTOSCOPY WAS PERFORMED, REVEALING AN EROSION OF THE CUFF. AS A RESULT, THE DEVICE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion

  MAUDE report 22751810 ↗
• InjuryJun 5, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NO LONGER FUNCTIONING AS INTENDED AND WAS CONFIRMED BY THE PHYSICIAN TO NOT BE WORKING PROPERLY. THE PATIENT HAS UNDERGONE ENTEROCYSTOPLASTY FOR THE SMALL CAPACITY AND PAIN OF THE BLADDER. THE AUS WAS EXPLANTED AND REPLACED WITH ROBOTIC-ASSISTED LAPAROSCOPIC SURGERY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 22150435 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGICAL PROCEDURE WAS PERFORMED TO EXPLANT THE ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO THE PATIENT EXPERIENCED A POSSIBLE INFECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 21878208 ↗
• InjurySep 11, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) REVISION SURGERY DUE TO THE DEVICE NOT WORKING. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17717369 ↗
• InjuryMay 11, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE THE ARTIFICIAL URINARY SPHINCTER REMOVED DUE TO INCONTINENCE AS THE DEVICE STOPPED WORKING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 16910791 ↗
• InjuryFeb 13, 2023Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) REPLACEMENT SURGERY DUE TO RECENT URINARY INCONTINENCE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE SYSTEM WAS DRAINED WHICH LED TO A MECHANICAL FAILURE. ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 16368884 ↗
• MalfunctionDec 10, 2020Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6.5 CM BELT CUFF BEFORE IMPLANTATION, IT WAS NOTICED THAT WAS UNABLE TO NORMALLY FILL WITH SALINE OR ASPIRATE THE SALINE OUT OF THE CUFF. IT APPEARS THAT SOMETHING IS BLOCKING THE TUBING WERE THE TUBING AND THE CUFF CONNECTS. AFTER MULTIPLE FILLING AND ASPIRATION ATTEMPTS, IT WAS DETERMINED THAT THE CUFF WAS FAULTY. THEREFORE, A NEW CUFF WAS OPENED AND PREPARED TO IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10989125 ↗
• InjuryJan 28, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE OVER THE PAST YEAR WITH A TWENTY ONE YEAR OLD ARTIFICIAL URINARY SPHINCTER (AUS). A REPLACEMENT SURGERY WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS REMOVED AND A NEW AUS WAS IMPLANTED. DURING THE PROCEDURE FLUID LOSS WAS NOTED DUE TO TUBING FROM PUMP BEING TORN; HOWEVER, THE REASON FOR THE TEAR WAS UNKNOWN. THE PATIENT DID NOT EXPERIENCE ANY FURTHER ADVERSE EVENTS. THE PATIENT WAS SAID TO BE GOOD AFTER THE PROCEDURE. NO MORE INFORMATION AVAILABLE AT THE MOMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED.

  Patient problems: Incontinence

  MAUDE report 9639143 ↗
• InjuryDec 13, 2019Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT AMS 800 ARTIFICIAL URINARY SPHINCTER CONSISTING OF CUFF, BALLOON, AND PUMP WAS REPLACED BECAUSE THE DEVICE WAS DEFECTIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9465447 ↗
• InjurySep 27, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DUE TO A PIERCED CUFF THE PATIENT HAD HIS ARTIFICIAL URINARY SPHINCTER (AUS) REMOVED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9131874 ↗
• InjuryJul 15, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) STARTED TO MALFUNCTION IN 2018. THE ENTIRE AUS SYSTEM WAS REMOVED AND REPLACED WITH A NEW ONE. NO FURTHER ISSUES WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8791830 ↗
• InjuryMar 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER CUFF AND BALLOON COMPONENTS REMOVED DUE TO UNSPECIFIED REASONS. THE PUMP REMAINED IMPLANTED. NEW ARTIFICIAL URINARY SPHINCTER CUFF AND BALLOON COMPONENTS WERE 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 8413664 ↗

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