AMS 800 Artificial Urinary Sphincter 720157-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 591 adverse event reports that list this exact device (DI 00878953005652), received between Sep 15, 2018 and Sep 23, 2026 — classified as 578 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (132 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 591 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erosion

  MAUDE report 50876218 ↗
• InjurySep 22, 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 explanted and replaced the device. There were no further patient complications.

  Patient problems: Urinary Incontinence

  MAUDE report 50857744 ↗
• InjurySep 17, 2026Fluid/Blood Leak

  It was reported that the Artificial Urinary Sphincter (AUS) was experiencing incontinence. Through imaging, fluid loss was observed. As a result, the device was explanted and replaced. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50803196 ↗
• InjurySep 15, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that after the six-week activation period for the Artificial Urinary Sphincter (AUS), the device did not activate and did not provide sufficient pressure for the cuff to coapt the urethra. As a result, the patient experienced urinary incontinence. Troubleshooting was performed, but it was unsuccessful. A cystoscopy was performed to visualize the cuff and verify that it was not providing sufficient pressure to close the urethra. A surgical procedure was performed, during which fluid loss was observed from a hole in the balloon; therefore, the balloon was removed and replaced. The original cuff and pump remained implanted. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50772511 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence due to tissue atrophy. The patient became more obese in recent years. A surgical procedure was performed to remove and replace the AUS. No further patient complications were reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50756609 ↗
• InjurySep 14, 2026Mechanical Problem

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence and atrophy. The device was not closing and not working properly. As a result, the device was explanted. No further patient complications were reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50754794 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with this Artificial Urinary Sphincter (AUS) experienced incontinence and urethral atrophy. A surgical procedure was performed during which the existing device was explanted and replaced with a new AUS. There were no further patient complications reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50754100 ↗
• InjurySep 8, 2026Fluid/Blood Leak; Mechanical Problem

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence and the cuff did not work due to fluid loss in the Pressure Regulating Balloon (PRB). As a result, the device was explanted. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50670423 ↗
• InjuryAug 18, 2026Insufficient Device Problem Information

  It was reported that this patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. A surgical procedure was performed during which the device was explanted. Upon explant the physician identified atrophy at the cuff. The patient fully recovered, and there was no additional information was provided.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50306558 ↗
• InjuryAug 11, 2026Adverse 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 and replaced. The cuff was being place more proximally. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50204135 ↗
• InjuryAug 6, 2026Fluid/Blood Leak; Mechanical Problem; Air/Gas in Device

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence. Upon inspection, air bubbles were identified within the cuff and pump, along with associated fluid loss. In addition, the cuff was noted to be not inflating. As a result, the device was explanted and replaced. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50167826 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Urinary Incontinence

  MAUDE report 25728066 ↗
• InjuryJun 30, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE AND PRESENTED WITH INABILITY TO FULLY COAPT THE URETHRA. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED URETHRAL TISSUE ATROPHY BENEATH THE CUFF. THE DEVICE WAS EXPLANTED AND REPLACED. A CYSTOSCOPY WAS PERFORMED AT THE END OF THE PROCEDURE, WHICH CONFIRMED THE NEW DEVICE WAS FUNCTIONING PROPERLY. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 25673605 ↗
• InjuryJun 24, 2026Mechanical Problem

  IT WAS REPORTED THAT THE ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH RECURRING INCONTINENCE AND THAT THE DEVICE WAS NO LONGER FUNCTIONING. A SURGICAL PROCEDURE WAS PERFORMED, AND THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 25616535 ↗
• InjuryJun 4, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. THE DEVICE WAS NOTED TO HAVE DECREASED COAPTATION STRENGTH. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Urinary Incontinence

  MAUDE report 25394942 ↗
• InjuryJun 2, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH RECURRING INCONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED, AND THE CUFF WAS REPLACED AS IT WAS TOO LARGE FOR THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 25368508 ↗
• InjuryJun 2, 2026Nonstandard Device

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE, AND THE DEVICE EXHIBITED POOR COAPTATION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE AUS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 25368099 ↗
• InjuryMay 28, 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 DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 25325875 ↗
• InjuryMay 27, 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 CONFIRMED URETHRAL CUFF EROSION; THEREFORE, THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 25310967 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED URETHRAL EROSION AND RECURRING INCONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE AUS TO ALLOW THE URETHRA TO HEAL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 25301774 ↗
• InjuryMay 21, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT FUNCTIONING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE AUS WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246651 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE AND AN ATROPHIED URETHRA. A SURGICAL PROCEDURE WAS PERFORMED, AND THE CUFF WAS EXPLANTED AND REPLACED. THERE WERE NO DEVICE ISSUES. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 25236936 ↗
• InjuryMay 14, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED PAIN AND DISCOMFORT IN THE PERINEUM. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH IT WAS IDENTIFIED THAT THE CAUSE WAS DUE TO THE CUFF BEING TOO TIGHT FOR THE PATIENT. A 3.5 CM CUFF WAS REMOVED, AND A NEW 4.0 CM CUFF WAS IMPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 25174352 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH RECURRING INCONTINENCE AND URETHRAL ATROPHY. THE AUS WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 25017893 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) IMPLANT DEVICE EXPERIENCED INCONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24958064 ↗

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-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