AMS 800 Artificial Urinary Sphincter 72400163Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00878953000749), received between Nov 7, 2018 and Sep 28, 2026 — classified as 56 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (22 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Material Puncture/Hole

  It was reported that this Artificial Urinary Sphincter (AUS) was not functioning properly. Upon inspection, a crack was found in the cuff connecting tube. A surgical procedure was performed during which the existing device was explanted and replaced with a new cuff (4.5). There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914680 ↗
• InjuryApr 24, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE CUFF HAD A HOLE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24986211 ↗
• InjuryFeb 23, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A HOLE IN THE CUFF WAS FOUND, RESULTING IN FLUID LOSS; THEREFORE, THE AUS WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24424673 ↗
• InjuryFeb 18, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S ARTIFICIAL URINARY SPHINCTER (AUS) WAS NO LONGER FUNCTIONING AND PATIENT EXPERIENCED RECURRING URINARY INCONTINENCE. NO NEW SURGERY HAS BEEN SCHEDULED YET. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Urinary Incontinence

  MAUDE report 24383509 ↗
• InjuryDec 29, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A HOLE IN THE CUFF WAS FOUND. THE CUFF WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917325 ↗
• InjuryDec 24, 2025Fluid/Blood Leak; Mechanical Problem; Difficult or Delayed Activation; Fluid/Blood Leak; Mechanical Problem; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS EXPERIENCING PERSISTENT URINARY INCONTINENCE FOLLOWING IMPLANTATION. APPROXIMATELY ONE MONTH AFTER THE PROCEDURE, AN ATTEMPT WAS MADE TO ACTIVATE THE DEVICE WITHOUT SUCCESS. A SUBSEQUENT ATTEMPT WAS MADE DURING WHICH THE BALLOON WAS OBSERVED TO EMPTY; HOWEVER, THE CUFF DID NOT FILL, AND URETHRAL COAPTATION WAS NOT ACHIEVED. THE PUMP WAS REPORTED TO FILL AND EMPTY, BUT FLUID WAS NOT DELIVERED TO THE CUFF, AND THE CUFF REMAINED UNCHANGED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23887758 ↗
• InjuryNov 10, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A CRACK IN THE CUFF CONNECTING TUBE WAS FOUND. THE AUS WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508864 ↗
• InjuryOct 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCE RECURRENT INCONTINENCE. A FIBROSCOPY WAS PERFORMED, REVEALING A CUFF WITH AN OCCLUSIVE APPEARANCE; HOWEVER, SUBSEQUENT PELVIC X-RAY IMAGING SHOWED AN EMPTY BALLOON. THEREFORE, THE AUS WAS CONSIDERED NONFUNCTIONAL, AND THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE AND REPLACE THE DEVICE. UPON REMOVAL, THE AUS WAS TESTED, REVEALING A HEALTHY BALLOON AND A LEAK AT THE CUFF. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23271474 ↗
• InjuryAug 27, 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) EXPERIENCED URETHRAL EROSION ON THE CUFF AND RECURRING URINARY INCONTINENCE. AS A RESULT, THE DEVICE WAS EXPLANTED AND SEVERAL MONTHS LATER, A NEW DEVICE WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 22909660 ↗
• InjuryAug 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE DUE TO A MECHANICAL FAILURE OF THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE AUS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22891744 ↗
• InjuryApr 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER IMPLANTED FOR A NEURAL MALFORMATION, WHO IS CURRENTLY UNDERGOING SELF CATHETERIZATION AND BOTULINUM TOXIN TREATMENT, EXPERIENCED RECURRENT INCONTINENCE THE PAST 3 YEARS, AS A RESULT OF THE DEVICE NO LONGER WORKING. A REPLACEMENT SURGERY WAS PERFORMED. THE DEVICE WAS EXPLANTED AND REPLACED, AND THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 21901303 ↗
• InjuryApr 23, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER EXPERIENCED THE DEVICE NOT FUNCTIONING PROPERLY. A REVISION SURGERY WAS PERFORMED DURING WHICH THE PHYSICIAN CONFIRMED THAT THE CUFF HAD A HOLE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892240 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ARTIFICIAL URINARY SPHINCTER (AUS) WAS IMPLANTED IN (B)(6) 2024. THEN, THE PATIENT HAS LOST MORE URINE IN THE LAST MONTHS. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM TO DOWNSIZING THE CUFF. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Incontinence

  MAUDE report 21854263 ↗
• InjuryJan 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED RECURRING INCONTINENCE DUE TO A FLUID LOSS IN THE DEVICE. THE AUS IS CURRENTLY IMPLANTED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 21254053 ↗
• InjuryDec 23, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AFTER 13 YEARS OF IMPLANTATION THIS ARTIFICIAL URINARY SPHINCTER STOPPED WORKING, POSSIBLY DUE TO URETHRAL ATROPHY. THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21008110 ↗
• InjuryNov 26, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) STOPPED WORKING, BELIEVED TO BE DUE TO FLUID LOSS. IN ADDITION, IT WAS NOTED THAT THE PATIENT FREQUENTLY BIKES, WHICH COULD CONTRIBUTE TO THE DEVICE ISSUE. TROUBLESHOOTING WAS ATTEMPTED TO NO AVAIL; THEREFORE, A SURGICAL PROCEDURE TO REMOVE THE AUS WAS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785180 ↗
• InjuryOct 29, 2024Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  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 CAUSE OF THE HOLE WAS NOT DETAILED BY THE HOSPITAL. THE CUFF WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563404 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER THE IMPLANT PROCEDURE OF THIS ARTIFICIAL URINARY SPHINCTER (AUS), THE PATIENT EXPERIENCED SEVERAL EPISODES OF URINE RETENTION, MAKE IT NECESSARY TO DEACTIVATE THE PUMP AND PERFORM A DELAYED BLADDER CATHETERIZATION. THE PATIENT DEVELOPED A URINARY TRACT INFECTION REQUIRING HOSPITALIZATION FOR INTRAVENOUS ANTIBIOTIC THERAPY, REQUIRING A SAFETY CYSTOSTOMY UNTIL THE CONDITION IMPROVE. THE PATIENT ALSO DEVELOPED HYPEREMIA AND PHLOGOSIS IN THE INGUINAL REGION, ASSOCIATED WITH FEVER. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH ALL COMPONENTS WERE REMOVED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erythema; Fever; Inflammation; Urinary Retention; Urinary Tract Infection

  MAUDE report 20365255 ↗
• InjurySep 10, 2024Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Malposition of Device; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO RECURRING INCONTINENCE. THE AUS WAS NOT WORKING. FLUID LOSS WAS OBSERVED DUE TO A HOLE IN THE CUFF. THE CUFF WAS AROUND THE CORPORA INSTEAD OF THE URETHRA. THE AUS WAS EXPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 20181562 ↗
• InjuryAug 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT, WHO HAD AN ARTIFICIAL URINARY SPHINCTER (AUS) DEVICE IMPLANTED, UNDERWENT A REVISION SURGERY DUE TO FLUID LOSS IN THE DEVICE. ALL COMPONENTS OF THE EXISTING AUS WERE EXPLANTED AND REPLACED WITH A NEW AUS. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920014 ↗
• InjuryJul 17, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT AN ARTIFICIAL URINARY SPHINCTER (AUS) WAS EXPLANTED DUE TO INCONTINENCE. IT WAS NOTED THAT DURING CYSTOSCOPY, THE CUFF HAD A LOW COAPTATION OF THE URETHRA. A NEW DEVICE WAS PLACED, AND NO OTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 19762493 ↗
• InjuryApr 4, 2024Fluid/Blood Leak; Material Puncture/Hole; Defective Device; Fluid/Blood Leak; Material Puncture/Hole; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) BEGAN TO EXPERIENCE URINARY INCONTINENCE UPON EXERTION. THE PATIENT STATES THAT HE HAS BEEN ABLE TO VOID WITHOUT CYCLING THE DEVICE. AT A LATER DATE, A REVISION SURGERY WAS PERFORMED; UPON EXAMINATION, FLUID LEAKAGE DUE TO A PINHOLE IN THE BALLOON WAS FOUND. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 19048041 ↗
• InjuryFeb 26, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED SEVERE URINARY INCONTINENCE. AFTER PERFORMING A CYSTOSCOPY, IT WAS NOTED THAT THE CUFF IS NOT OPENING OR CLOSING. THE DEVICE REMAINS IMPLANTED, AND A REVISION SURGERY IS BEING CONSIDERED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 18784349 ↗
• InjurySep 5, 2023Inadequacy 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 URINARY INCONTINENCE WHEN COUGHING OR LIFTING HEAVY OBJECTS DUE TO THE LENGTH OF THE CUFF. A MONTH LATER A REVISION SURGERY WAS PERFORMED. UPON EXAMINATION, THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE CUFF WITH A SMALLER ONE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 17687545 ↗
• InjuryAug 10, 2023Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER EXPERIENCED RECURRING INCONTINENCE AS THE DEVICE STOPPED WORKING. UPON EXPLANT, IT WAS NOTED THAT THE SYSTEM DID NOT HAVE ANY FLUID; HOWEVER, THE SOURCE OF THE FLUID LOSS COULD NOT BE IDENTIFIED. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 17500148 ↗

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