AMS 800 Artificial Urinary Sphincter 720133-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00878953005461), received between Oct 24, 2018 and Sep 28, 2026 — classified as 95 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (29 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 99 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Incontinence

  MAUDE report 50916183 ↗
• InjurySep 22, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) presented to the hospital with a non-functional device. Two weeks later, a surgical procedure was performed and upon inspection, there was a hole found in the cuff. As a result, the physician removed and replaced the entire device. The patient was stable following the procedure, and there was no additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859400 ↗
• InjuryAug 3, 2026Inadequacy 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 recurring urinary incontinence. As a result, the device was explanted. No further patient complications were reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50123830 ↗
• InjuryJun 2, 2026Fluid/Blood Leak; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. THE DEVICE EXHIBITED FLUID LOSS DUE TO A HOLE IN THE CUFF. AS A RESULT, THE AUS WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 25368126 ↗
• InjuryDec 16, 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) IMPLANT DEVICE WAS NOTED TO HAVE URETHRAL ATROPHY. THE FIRST IMPLANT CUFF SIZE WAS 3.5 CM, AND THE NEW CUFF IMPLANT WAS 4.0 CM. THE PHYSICIAN DID NOT BELIEVE THE CUFF WAS THE INCORRECT SIZE FOR THE PATIENT WHEN INITIALLY PLACED. THE PHYSICIAN REPORTED THAT THE ATROPHY OCCURRED AFTER 8 YEARS OF THE FIRST IMPLANT SURGERY, IN LINE WITH STUDIES AVAILABLE. ADDITIONALLY, THE PHYSICIAN BELIEVES THE CUFF WAS INITIALLY PLACED IN THE CORRECT LOCATION. THE PHYSICIAN REMOVED AND REPLACED THE DEVICE THROUGH REPLACEMENT SURGERY, AND THERE WERE NO FURTHER SIGNS OR SYMPTOMS REPORTED. THERE WERE NO DEVICE ISSUES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23822336 ↗
• InjuryNov 25, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT FUNCTIONING AS PROPERLY. DURING THE SURGICAL PROCEDURE, A CRACK WAS FOUND IN THE CUFF CONNECTING TUBE. THE CUFF WAS REPLACED, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649784 ↗
• InjurySep 9, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE 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 CRACK IN THE CUFF CONNECTING TUBE WAS IDENTIFIED. THE CAUSE OF CRACK IN THE CUFF CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. ALL THE COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012033 ↗
• InjuryJun 10, 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 EXPERIENCED RECURRENCE INCONTINENCE. A REPLACEMENT SURGERY WAS PERFORMED IN WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 22177554 ↗
• InjuryMay 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 URETHRAL ATROPHY, CAUSING THE DEVICE NO LONGER COMPRESSED THE URETHRA AS INTENDED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE CUFF. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury; Urethral Stenosis/Stricture

  MAUDE report 22095127 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCONTINENCE SINCE 2023. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE ALL THE SYSTEM. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Incontinence

  MAUDE report 21903930 ↗
• InjuryApr 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE ARTIFICIAL URINARY SPHINCTER (AUS) CUFF CONNECTING TUBE PRESENTED A CRACK. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE CUFF AND PUMP. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21814515 ↗
• MalfunctionFeb 18, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF THIS ARTIFICIAL URINARY SPHINCTER (AUS) APPEARED TO HAVE AN INCOMPLETE SEAL. DUE TO CONCERN OF CONTAMINATION, THE PRODUCT WAS NOT USED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403686 ↗
• InjuryFeb 6, 2025Mechanical 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 THIS PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED PROBLEMS AS THE DEVICE WAS NOT WORKING CORRECTLY. A SURGICAL PROCEDURE WAS PERFORMED WHERE IT WAS FOUND THAT THERE WAS A CRACK IN THE CUFF TUBING; THEREFORE, THE CUFF WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323934 ↗
• InjuryFeb 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL TWO WEEKS BEFORE THE OPERATION BECAUSE THE ARTIFICIAL URINARY SPHINCTER (AUS) DID NOT WORK PROPERLY. AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THERE WAS A CRACK IN THE CUFF CONNECTING TUBE, DUE TO THIS, ALL COMPONENTS WERE REPLACED. THE SURGERY WAS COMPLETED WITH A DIFFERENT CUFF 4.5CM. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318490 ↗
• InjuryFeb 5, 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 21313754 ↗
• InjuryDec 30, 2024Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH INFLATION ISSUES IN THE PUMP AND FLUID LOSS IN THE CUFF WERE NOTED; THEREFORE, ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPILATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037212 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ARTIFICIAL URINARY SPHINCTER (AUS) DEVICE WAS RETURNED WITH NO INFORMATION OR ANY PRODUCT PERFORMANCE ALLEGATION INFORMATION. ANALYSIS OF THE RETURNED COMPONENT IDENTIFIED THAT THE CUFF, BALLOON AND PUMP FAILED FUNCTIONAL TESTING AND VISUAL INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20691527 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO RECURRING INCONTINENCE AND SUB-CUFF ATROPHY. THE AUS AS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 20171016 ↗
• InjuryAug 29, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH CONTINUED INCONTINENCE AFTER THE IMPLANT OF THE DEVICE. THE PHYSICIAN PERFORMED TESTING AND DETERMINED THE DEVICE WAS WORKING NORMALLY. THE PATIENT STATES THAT THE DEVICE IS NO LONGER WORKING AND THEY WOULD LIKE ANOTHER PHYSICIAN TO EVALUATE THE DEVICE.

  Patient problems: Urinary Incontinence; Urinary Retention

  MAUDE report 20096215 ↗
• InjuryAug 26, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING AS INTENDED. THE PHYSICIAN EXPLANTED THE AUS AND FOUND A CRACK IN THE CUFF CONNECTING TUBE. A NEW AUS WAS IMPLANTED. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066263 ↗
• InjuryJun 4, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING AS EXPECTED DUE TO A CRACK IN THE CUFF CONNECTING TUBE. THE CUFF WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462069 ↗
• InjuryMay 20, 2024Inadequacy 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), UNDERWENT RADIATION THERAPY AND HIS URETHRA SHRUNK IN SIZE. THE PATIENT BEGAN TO EXPERIENCE INCONTINENCE. THE PHYSICIAN PERFORMED A CYSTOSCOPY AND DETERMINED THE CUFF NO LONGER FIT PROPERLY. THE ENTIRE AUS WAS REPLACED WITH A CUFF THAT FIT THE PATIENT BETTER. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 19355510 ↗
• InjuryApr 12, 2024Adverse 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 AN INFECTION. THE AUS WAS EXPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19098584 ↗
• InjuryJan 15, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18514983 ↗
• InjuryNov 29, 2023Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING PROPERLY. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A HOLE IN THE CUFF WAS FOUND. THE BALLOON REMAINED IMPLANTED, AND THE CUFF AND PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233815 ↗

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