AMS 800 Artificial Urinary Sphincter 72400023Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00878953000619), received between Jun 17, 2019 and Sep 21, 2026 — classified as 25 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Incontinence

  MAUDE report 50848710 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE. DURING A REVISION SURGERY, THE PHYSICIAN DETERMINED THAT A HIGHER PRESSURE BALLOON WAS NEEDED; THEREFORE, THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24866768 ↗
• InjuryJan 27, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED RECURRING INCONTINENCE, IT WAS REPORTED A FLUID LOSS DUE TO A HOLE IN THE BALLOON. THE BALLOON WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24190309 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE DUE TO NEUROLOGICAL SPASMS. NO DEVICE ISSUES WERE FOUND; HOWEVER, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE BALLOON AND REPLACE IT WITH A HIGHER PRESSURE ONE. THE PATIENT SPASMS ARE FROM ANOTHER CONDITION NOT RELATING TO THE DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22639040 ↗
• InjuryJul 1, 2025Fluid/Blood Leak; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE. A CYSTOSCOPY WAS PERFORMED AND REVEALED THAT ALTHOUGH THE CUFF WAS CLOSED, THE URETHRA REMAINED OPEN. IT WAS CONSIDERED THAT THE CUFF SIZE MIGHT NO LONGER BE APPROPRIATE. DURING SURGERY, IT WAS CONFIRMED THAT THE PRESSURE-REGULATING BALLOON WAS LEAKING SALINE SOLUTION. THE DEVICE COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22375169 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS ASSOCIATED WITH RECURRING URINARY INCONTINENCE. THE CUFF APPEARED TO BE FUNCTIONING PROPERLY; HOWEVER, THE PHYSICIAN ELECTED TO REPLACE THE ORIGINAL PRESSURE-REGULATING BALLOON (PRB) WITH A HIGHER PRESSURE PRB TO IMPROVE CONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED, AND CYSTOSCOPY CONFIRMED THE IMPLANT LOOKED APPROPRIATE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22311863 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT, DURING THE IMPLANTATION OF AN ARTIFICIAL URINARY SPHINCTER AUS DEVICE, THE BALLOON MIGRATED AND PROLAPSED INTO THE INGUINAL REGION, PRESENTING AS AN INGUINAL HERNIA. A SURGICAL PROCEDURE FOR THE HERNIA REPAIR WAS SCHEDULED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Hernia

  MAUDE report 22198061 ↗
• InjuryMay 23, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT MEDICAL IMAGING REVEALED FLUID LOSS IN THE BALLOON OF THIS ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO A HOLE IN THE COMPONENT'S NECK. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078508 ↗
• InjuryJan 9, 2025Fluid/Blood Leak; Mechanical Problem; Defective Device; Fluid/Blood Leak; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. IN ADDITION, THE DEVICE WAS NOT WORKING PROPERLY, AND THE PUMP WAS RIGID. A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED, DURING WHICH IT WAS NOTED THAT THE BALLOON WAS COLLAPSED; THEREFORE, THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO REMOVE AND REPLACE THE AUS. UPON EXPLANT, A TOTAL LOSS OF FLUID FROM THE BALLOON AND CUFF WAS IDENTIFIED, WHILE THE PUMP WAS STILL RETAINING FLUID. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 21112289 ↗
• InjuryNov 25, 2024Fluid/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 WAS NOT CYCLING PROPERLY, BELIEVED TO BE DUE TO A LEAK IN THE BALLOON; THEREFORE, A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE COMPONENT. THERE WERE NO DEVICE ISSUES AND NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 20774331 ↗
• InjuryAug 26, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH RECURRING INCONTINENCE. THE AUS WAS REPLACED, AND THE PHYSICIAN FOUND A HOLE IN THE PRESSURE REGULATING BALLOON (PRB) THAT RESULTED IN A FLUID LEAK FROM THE DEVICE. THERE WAS NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 20066398 ↗
• InjuryJun 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER EXPERIENCED RECURRENT INCONTINENCE APPROXIMATELY ONE AND A HALF YEARS POST-IMPLANT. IT WAS CONFIRMED THAT THE BALLOON WAS DAMAGED. NO NEW DEVICE WILL BE IMPLANTED DUE TO THE PATIENT CONDITION OF DEMENTIA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 19483404 ↗
• InjuryJun 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO FLUID LOSS FROM THE BALLOON. THE CUFF CAME OUT FIRST AND UPON REMOVAL OF THE BALLOON A BLEED STARTED THAT THE PHYSICIAN COULD NOT LOCATE. A VASCULAR SURGEON WAS CALLED IT TO LOCATE THE VEIN AND STOP THE BLEEDING. THE DEVICE WAS THEN REMOVED, BUT NO REPLACEMENT WAS IMPLANTED. THE PROCEDURE WAS THEN CANCELLED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 19476688 ↗
• MalfunctionApr 10, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) THAT WAS NOT WORKING AS INTENDED. THE PHYSICIAN PERFORMED A CYSTOSCOPY AND DETERMINED THERE WAS A FLUID LEAK FROM THE DEVICE. THERE HAS BEEN NO SURGICAL INTERVENTION, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085415 ↗
• InjuryOct 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER WAS REMOVED DUE TO A LEAK IN THE BALLOON RESULTING IN INCONTINENCE. A NEW ARTIFICIAL URINARY SPHINCTER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 18004185 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ARTIFICIAL URINARY SPHINCTER (AUS) HAD THE PRESSURE REGULATED BALLOON RETURNED WITHOUT INITIAL REPORTER AND PERFORMANCE ALLEGATION INFORMATION. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE BALLOON FAILED FUNCTIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645504 ↗
• InjuryDec 13, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INCONTINENCE WITH HIS ARTIFICIAL URINARY SPHINCTER (AUS). THE PRESSURE REGULATING BALLOON (PRB) WAS COLLAPSED. THE DEVICE REMAINS IMPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Urinary Incontinence

  MAUDE report 15971737 ↗
• InjuryNov 15, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) SURGERY DUE TO RECURRING INCONTINENCE. NO LEAK WERE FOUND IN THE DEVICE, BUT THE BALLOON WAS REMOVED AND REPLACED WITH A NEW ONE WITH HIGHER PRESSURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 15798624 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING BALLOON WAS REMOVED AND REPLACED WITH ONE OF MORE PRESSURE. IT WAS MENTIONED THAT THERE WERE NO DEVICE ISSUES WITH THE PREVIOUS DEVICE, ORIGINALLY A SMALLER BALLOON HAD BEEN PLACED AS THE PATIENT WAS HIGH RISK. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 15756067 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT, WITH AN ARTIFICIAL URINARY SPHINCTER (AUS), EXPERIENCED INCONTINENCE AFTER THE INITIAL IMPLANT. THE PHYSICIAN BELIEVED THAT A LARGER AUS PRESSURE REGULATING BALLOON (PRB) WOULD PROVIDE ENOUGH PRESSURE TO PROVIDE COAPTATION OF THE URETHRA AND WOULD BETTER FIT THE PATIENT. THE SMALLER PRB WAS EXPLANTED, AND A LARGER PRB WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 14635578 ↗
• InjurySep 8, 2021Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A ROUTINE VISIT TO THE PHYSICIAN THE PATIENT WAS EXPERIENCING INCREASED INCONTINENCE WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE PATIENT UNDERWENT A CYSTOSCOPY IN WHICH IT WAS CONFIRMED THAT THE DEVICE WAS NOT COOPERATING. THE PHYSICIAN SUSPECTED FLUID LOSS AS THE CAUSE FOR THE DEVICE NOT WORKING. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING BALLOON WAS REMOVED AND REPLACED. UPON EXPLANT, SALINE SOLUTION WAS INJECTED IN THE BALLOON, REVEALING TWO LARGE TEARS IN THE COMPONENT. THE PATIENT WAS EXPECTED TO FULLY RECOVER FOLLOWING THE INTERVENTION.

  Patient problems: Urinary Incontinence

  MAUDE report 12438870 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN HAVING SYMPTOMS OF INCONTINENCE SINCE (B)(6) 2020. THE PATIENT PREVIOUSLY RECEIVED A PRESSURE REGULATING BALLOON (PRB) OF 51-60ML BECAUSE HE HAS A COMPLICATED AND AT-RISK ANATOMY. THE PHYSICIAN DEEMED NECESSARY TO REPLACE THE 51-60ML PRB WITH A 61-70ML PRB DUE TO PATIENT ANATOMY AND SYMPTOMS. THERE WERE NO PROBLEMS INDICATED WITH THE PRB. THE REVISION SURGERY WAS CONDUCTED SUCCESSFULLY AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Urinary Incontinence

  MAUDE report 12325622 ↗
• InjuryJul 16, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REVISE AN ARTIFICIAL URINARY SPHINCTER(AUS) DUE TO RECURRING INCONTINENCE TWO AND A HALF YEARS AFTER THE AUS WAS IMPLANTED. WHEN THE AUS WAS EXPLANTED, A HOLE WAS FOUND IN THE PRB. A NEW PUMP AND PRB WAS IMPLANTED AND THE DEVICE WAS TESTED AND FULLY FUNCTIONING AFTER VERIFICATION BY CYSTOSCOPE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 12180962 ↗
• InjuryJan 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DUE TO AN UNSPECIFIED REASON THE PATIENT HAD HIS ARTIFICIAL URINARY SPHINCTER (AUS) 61-70 CM PRESSURE REGULATING BALLOON (PRB) REMOVED AND REPLACED WITH A 71-80 CM PRB. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING "SPONTANEOUS LEAKAGE" AND THE PHYSICIAN WANTED TO INCREASE THE BALLOON PRESSURE FROM 61-70 CM TO 71-80 CM BALLOON. IT WAS NOTED THAT THE APPROACH FOR THIS SURGERY WAS IN THE ABDOMINAL AREA WHERE THE OLD BALLOON WAS LOCATED AND THE NEW BALLOON WAS CONNECTED WITH PUMP AND CUFF AT THE SAME LOCATION. THERE WAS NO HANDING OF THE OLD CUFF AND PUMP. THE ONSET OF THE PATIENT SYMPTOMS WAS TWO MONTHS PREVIOUS TO THIS SURGERY. THE PATIENT WAS STABLE AFTER THIS SURGERY AND THE SYSTEM WILL BE ACTIVATED A WEEK AFTER THIS SURGERY.

  Patient problems: Incontinence

  MAUDE report 9629003 ↗
• InjuryNov 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) REVISION SURGERY DUE TO HE BECAME URINARY INCONTINENT. THE PRESSURE REGULATING BALLOON (PRB) WAS REMOVED AND REPLACED WITH A NEW 51-10 CM PRB. THE PATIENT HAD A GOOD OUTCOME WITH NO FURTHER COMPLICATIONS. NO MORE INFORMATION IS AVAILABLE AT THE MOMENT, ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED AS RELEVANT INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION RECEIVED. THERE WAS LEAKING FROM THE TUBING WHERE IT INSERTS INTO THE BALLOON PART OF THE PRB WHEN THE PHYSICIAN TESTED IT AT THE BACK TABLE.

  Patient problems: Incontinence

  MAUDE report 9309383 ↗

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-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-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-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