AMS 800 Artificial Urinary Sphincter 72400168Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00878953000794), received between Apr 19, 2019 and Mar 17, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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.

• MalfunctionMar 17, 2026Material Discolored

  IT WAS REPORTED THAT DURING THE SURGICAL IMPLANTATION OF AN ARTIFICIAL URINARY SPHINCTER (AUS), FLUID DROPLETS RESEMBLING CONDENSATION WERE OBSERVED INSIDE THE CUFF IMMEDIATELY UPON OPENING THE PACKAGING. ADDITIONAL CUFFS WERE SUBSEQUENTLY OPENED AND INSPECTED, AND SIMILAR FINDINGS WERE OBSERVED. AS A RESULT, THE INTENDED IMPLANTATION COULD NOT BE COMPLETED. THE INTERVENTION WAS ABORTED, A TEMPORARY ALTERNATIVE PROCEDURE WAS PERFORMED, AND THE PATIENT'S AUS IMPLANTATION WAS RESCHEDULED FOR A LATER DATE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620930 ↗
• InjuryFeb 4, 2026Fluid/Blood Leak; Mechanical Problem; Decrease in Pressure

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT URINARY INCONTINENCE AND LOWER URINARY TRACT INFECTIONS FOR SEVERAL MONTHS. ENDOSCOPIC EXAMINATION REVEALED A NON-OCCLUSIVE CUFF, AND ABDOMINAL ULTRASOUND DEMONSTRATED A PROGRESSIVE AND STEADY DECREASE IN BALLOON VOLUME. THESE FINDINGS ARE CONSISTENT WITH A PROBABLE MICRO LEAK WITHIN THE SYSTEM. THE AUS WAS COMPLETELY REMOVED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Urinary Incontinence; Urinary Tract Infection

  MAUDE report 24262118 ↗
• InjurySep 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. UPON REVISION, A FLUID LOSS WAS IDENTIFIED; THEREFORE, THE AUS WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22967064 ↗
• InjuryFeb 1, 2023Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER REMOVED AS THERE WAS NO FLUID IN THE BALLOON AND THE DEVICE WASN'T CYCLING PROPERLY RESULTING IN INCONTINENCE. A NEW ARTIFICIAL URINARY SPHINCTER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 16281425 ↗
• InjuryApr 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NONFUNCTIONAL ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCING URINARY INCONTINENCE. UPON SURGICAL EXPLORATION, IT WAS DETERMINED THAT THE ORIGINAL CUFF HAD BEEN REMOVED AT AN UNKNOWN DATE. THE REMAINING TWO COMPONENTS (PUMP AND BALLOON) WERE REMOVED AND A NEW AUS SYSTEM WAS PLACED SUCCESSFULLY. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Urinary Incontinence

  MAUDE report 14074797 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER SIX WEEKS OF THE ARTIFICIAL URINARY SPHINCTER (AUS) IMPLANTATION, THE CUFF IS UNABLE TO CLOSE THE BLADDER NECK, EVEN THOUGH THE DEVICE IS FUNCTIONAL. THEREFORE, THE PATIENT IS EXPERIENCING RECURRING INCONTINENCE. A REVISION SURGERY WAS REQUESTED TO REMOVE THE BLADDER CUFF AND PLACE A NEW CUFF ON THE BULBAR URETHRA. THE REVISION SURGERY HAS NOT BEEN PLANNED.

  Patient problems: Urinary Incontinence

  MAUDE report 13551769 ↗
• InjuryApr 15, 2021Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER REMOVED DUE TO FLUID LOSS FROM A CUFF DEFECT. 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: Incontinence; Insufficient Information; Urinary Incontinence

  MAUDE report 11674913 ↗
• InjuryAug 23, 2019Material Puncture/Hole; Inadequacy of Device Shape and/or Size; Material Puncture/Hole; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE WITH THE AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO TWO HOLES FOUND IN THE CUFF UPON REMOVAL. AN ENDOSCOPY ASSESSMENT SHOWED ABSENCE OF EROSION AND THE CUFF APPEARED TOO BIG. THE AUS CUFF WAS REMOVED AND REPLACED WITH A NEW CUFF. NO FURTHER ISSUES WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Incontinence

  MAUDE report 8926118 ↗
• InjuryAug 12, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE WITH THE AMS 800 ARTIFICIAL URINARY SPHINCTER. URETHROSCOPY ASSESSMENT SHOWED ABSENCE OF EROSION, BUT THE CUFF HEAD APPEARED TO BE TOO LARGE. IT WAS DECIDED TO REMOVE AND REPLACE THE CONTROL PUMP AND CUFF. THE EXPLANTED CUFF TWO HOLES WHICH COULD EXPLAIN THE LEAKAGE.

  Patient problems: Incontinence

  MAUDE report 8885037 ↗
• InjuryApr 24, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY INCONTINENCE THAT STARTED IN (B)(6) 2019 DUE TO A CUFF PERFORATION WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS CUFF, PUMP, AND BALLOON WAS EXPLANTED AND A NEW AUS CUFF, PUMP, AND BALLOON WAS IMPLANTED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS.

  Patient problems: Incontinence

  MAUDE report 8546932 ↗
• MalfunctionApr 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DUE TO A PRESENCE OF A LEAK ON THE TUBE BEFORE SETTING UP, THE PATIENT HAD HIS ARTIFICIAL URINARY SPHINCTER (AUS) NOT USED. THERE WERE NO CLINICAL CONSEQUENCES RELATED TO THIS EVENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8532604 ↗

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