AMS 800 Artificial Urinary Sphincter 72400164Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00878953000756), received between Oct 30, 2018 and Apr 24, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Migration

  IT WAS REPORTED THAT AN ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT FUNCTIONING DUE TO LATERAL DISLOCATION OF THE CUFF WITHIN THE URETHRA, AS IDENTIFIED DURING A MEDICAL EXAMINATION. A SURGICAL PROCEDURE WAS PERFORMED TO RELOCATE THE CUFF. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983015 ↗
• InjuryMar 11, 2026Disconnection; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE DUE TO A SUSPECTED FLUID LEAK ASSOCIATED WITH A CUFF CONNECTION ISSUE, RESULTING IN PARTIAL DEVICE FUNCTION. A REVISION SURGERY WAS SCHEDULED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 24573013 ↗
• InjuryDec 22, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT SINCE DEVICE ACTIVATION, THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. THE ISSUE MAY BE RELATED TO A LOOSE CUFF, BALLOON NOT FUNCTIONING PROPERLY, AND IMPROPER PUMP INFLATION. TROUBLESHOOTING ATTEMPTS WERE UNSUCCESSFUL. THE DEVICE REMAINS IMPLANTED, AND SURGERY IS PLANNED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23862797 ↗
• InjuryNov 19, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH RECURRING INCONTINENCE. THE PHYSICIAN SCOPED THE PATIENT AND CYCLED THE ARTIFICIAL URINARY SPHINCTER (AUS) IMPLANT DEVICE AND DETERMINED THAT THE CUFF WAS NOT FULLY OCCLUDING. THE MOST LIKELY/SUSPECTED CAUSE OF THE RECURRING INCONTINENCE WAS THE CUFF SIZE WAS TOO LARGE. THE PHYSICIAN REMOVED AND REPLACED THE DEVICE THROUGH REPLACEMENT SURGERY, AND BY MEASURING AND DOWNSIZING THE CUFF TO THE CORRECT MEASUREMENT TO FIT CORRECTLY. THERE WERE NO FURTHER SIGNS OR SYMPTOMS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23595803 ↗
• InjuryNov 17, 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) DEVELOPED PAIN NEAR THE PUMP SITE, FOLLOWED BY EDEMA AND INFLAMMATION. THE PATIENT WAS STARTED ON ANTIBIOTIC THERAPY, BUT THE CONDITION PROGRESSED TO EROSION AND EXTERIORIZATION OF THE PUMP THROUGH THE RIGHT LABIA MAJORA. CLINICAL EVALUATION CONFIRMED A LOCALIZED INFECTION AT THE PUMP SITE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED AS AN EMERGENCY INTERVENTION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23577486 ↗
• InjuryOct 15, 2025Fluid/Blood Leak; Nonstandard Device; Fluid/Blood Leak; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED URINARY TRACT SYMPTOMS INCLUDING URGENCY, WHICH PROGRESSED TO TOTAL URINARY INCONTINENCE. A PELVIC X-RAY WAS PERFORMED AND REVEALED A FLUID LOSS WITHIN THE SYSTEM; THEREFORE, THE AUS WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Micturition Urgency; Urinary Incontinence

  MAUDE report 23297265 ↗
• InjuryJan 2, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED INCONTINENCE. IT WAS NOTICED THAT THE CUFF WAS SLIGHTLY OVERSIZED FOR PATIENT'S URETHRA. THE CUFF WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 21056427 ↗
• InjuryOct 24, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC BECAUSE THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A HOLE IN THE CUFF WAS IDENTIFIED. THE AUS WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524749 ↗
• InjuryOct 2, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE ARTIFICIAL URINARY SPHINCTER (AUS) CUFF WAS TOO LOOSE. AS A RESULT, THE PATIENT WAS STILL EXPERIENCING URINARY INCONTINENCE. THE AUS CUFF WAS EXPLANTED, AND A NEW SMALLER CUFF WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 20350127 ↗
• InjuryMay 10, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING REOCCURRING INCONTINENCE. A CYSTOSCOPY WAS PERFORMED, AND IT WAS NOTICED THAT THE ARTIFICIAL URINARY SPHINCTER (AUS) DID NOT HAVE A COMPLETE COAPTATION. THE AUS SYSTEM WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 16901925 ↗
• InjuryFeb 22, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AFTER URETHROPLASTY AND RADIATION, THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) STARTED TO EXPERIENCE URINARY INCONTINENCE. A REPLACEMENT SURGERY WAS PERFORMED IN WHICH ALL COMPONENTS WERE REMOVED AND REPLACED. A SMALLER CUFF WAS NEEDED BECAUSE THE PRIOR PROCEDURE AFFECTED THE FIT OF THE CUFF. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 16422249 ↗
• InjuryMar 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) REPLACEMENT SURGERY DUE TO AN EROSION. THERE WERE NO FURTHER PATIENT COMPLICATIONS NOR DEVICE ISSUES.

  Patient problems: Erosion

  MAUDE report 13660770 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER CUFF COMPONENT REMOVED DUE TO URETHRAL ATROPHY RESULTING IN RECURRING INCONTINENCE. A NEW ARTIFICIAL URINARY SPHINCTER CUFF WAS IMPLANTED. FOLLOWING THE SURGERY, THE PATIENT WAS STABLE AND THE EVENT RESOLVED.

  Patient problems: Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 11946598 ↗
• InjuryMay 18, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER REMOVED DUE TO RECURRING INCONTINENCE DUE TO A HOLE IN THE CUFF. THE PATIENT HAD OBSERVED THE SUDDEN RECURRENCE OF STRESS URINARY INCONTINENCE SINCE (B)(6) 2019, CLEAR COUGH LEAKS, NOCTURNAL LEAKS, WHICH REQUIRED THE USE OF TWO PROTECTIONS, AS OF (B)(6) 2020. A NEW ARTIFICIAL URINARY SPHINCTER CONSISTING OF A CUFF, PUMP, AND BALLOON WAS IMPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 11841315 ↗
• InjuryJan 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REIMPLANT THIS ARTIFICIAL URINARY SPHINCTER (AUS) DEVICE DUE TO FLUID LOSS. THE AUS CUFF, PUMP, AND BALLOON WAS EXPLANTED IN 2019 AND NO NEW DEVICE WAS IMPLANTED. ON (B)(6) 2020 A NEW AUS CUFF, PUMP, AND BALLOON WAS IMPLANTED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11165469 ↗
• MalfunctionDec 16, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PHYSICIAN REQUESTED A SURGICAL REVIEW OF AN ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO AN UNSPECIFIED PROSTHESIS DEFECT. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT'S OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11022709 ↗
• InjuryOct 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SURGICAL PROCEDURE TO REMOVE AN ARTIFICIAL URINARY SPHINCTER(AUS) CUFF DUE TO AN INFECTION. THE PATIENT LATER HAD A SURGERY TO REIMPLANT THE AUS. A PATIENT OUTCOME OF STABLE WAS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 10632074 ↗
• InjuryApr 17, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DUE TO AN PROSTHESIS FAILURE THE PATIENT HAD HER ARTIFICIAL URINARY SPHINCTER (AUS) REMOVED AND REPLACED. THE AUS WAS EXPLANTED AND A NEW DEVICE CONSISTING OF A 4.0 CM CUFF, PUMP AND BALLOON WERE IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8524886 ↗
• InjuryFeb 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) REVISION SURGERY DUE TO RECURRING INCONTINENCE. THE 6.0 CM CUFF COMPONENT FROM THE EXISTING AUS WAS EXPLANTED AND REPLACED WITH A NEW 5.0 CM CUFF. THE EXPLANTED 5.0 CM CUFF IS NOT EXPECTED TO BE RETURNED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, OR PRODUCT BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE PRODUCT ANALYSIS.

  Patient problems: Incontinence

  MAUDE report 8339953 ↗
• InjuryOct 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN ARTIFICIAL URINARY SPHINCTER EXPLANTED AND REPLACED DUE TO SCROTAL MASS INFECTION AND THE BELT CUFF EROSION THROUGH THE URETHRA. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED.

  Patient problems: Erosion; Swelling; Unspecified Infection

  MAUDE report 8021823 ↗

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