AMS 800 Artificial Urinary Sphincter 72400161Recalls & reported problems

Summary

The FDA's MAUDE database contains 358 adverse event reports that list this exact device (DI 00878953000725), received between Oct 10, 2018 and Sep 29, 2026 — classified as 335 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (129 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 358 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Puncture/Hole

  Patient problems: Urinary Incontinence

  MAUDE report 50933064 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this patient with an Artificial Urinary Sphincter (AUS) and a history of radical prostatectomy experienced recurring incontinence. The physician performed a pelvic x-ray with both the AUS open and closed and noted there was no leakage from the device. A surgical procedure was performed during which the device was explanted and replaced. The preoperative urine culture was positive, and the patient underwent a 48-hour course of antibiotic therapy. No additional information was provided.

  Patient problems: Unspecified Infection; Urinary Incontinence

  MAUDE report 50859399 ↗
• InjurySep 18, 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 AUS. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818067 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence due to urethral atrophy. A surgical procedure was performed during which the existing device was explanted and replaced with a new IPP with a smaller cuff and a 1-70 PRB filled with 24cc. There were no further patient complications reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50714007 ↗
• InjurySep 8, 2026Inflation Problem; Mechanical Problem; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678514 ↗
• InjurySep 8, 2026Malposition of Device

  It was reported that the patient with an Artificial Urinary Sphincter (AUS) experienced worsening urinary incontinence. It was further reported that tissue atrophy was suspected to be the cause of the recurring incontinence and that the original cuff placement location was not believed to be optimal. A revision procedure was performed during which the entire AUS system was explanted and replaced, including implantation of a 5.0 cm cuff. No patient complications were reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50674964 ↗
• InjuryAug 24, 2026Mechanical Problem

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence due to wear of the device over time. A surgical procedure was performed during which the AUS was replaced. No further information was provided.

  Patient problems: Urinary Incontinence

  MAUDE report 50408007 ↗
• InjuryAug 19, 2026Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331336 ↗
• InjuryAug 4, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient's Artificial Urinary Sphincter (AUS) was not functioning properly. During a surgical procedure, a crack was identified in the cuff connecting tubing. The cuff was explanted and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50134456 ↗
• InjuryJul 31, 2026Mechanical Problem; Nonstandard Device

  It was reported that a cuff on an Artificial Urinary Sphincter (AUS) exhibited a mechanical issue. A surgical procedure was performed to remove and replace the cuff. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50106263 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT FUNCTIONING PROPERLY. THE PATIENT EXPERIENCED RECURRENT URINARY INCONTINENCE AND PRESENTED WITH BLADDER LESIONS. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE AUS WAS COMPLETELY REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 25461076 ↗
• InjuryMay 6, 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 CUFF. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095799 ↗
• InjuryMar 31, 2026Fluid/Blood Leak; Mechanical Problem; Decrease in Pressure

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. THE DEVICE WAS NOT FUNCTIONING PROPERLY, AS THE CUFF DID NOT ACHIEVE FULL COAPTATION AND THE BALLOON DID NOT MAINTAIN APPROPRIATE SYSTEM PRESSURE. NO VISIBLE KINKS OR DISCONNECTIONS WERE NOTED, THOUGH A SLOW LEAK COULD NOT BE RULED OUT. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24742504 ↗
• InjuryMar 25, 2026Disconnection; Fluid/Blood Leak; Mechanical Problem; Nonstandard Device; Decrease in Pressure

  IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE AND PRESENTED WITH A NONFUNCTIONING DEVICE. DURING A REVISION SURGERY, THE PHYSICIAN STATED THAT THE PRESENTATION WAS CONSISTENT WITH INSUFFICIENT CUFF COAPTATION. FLUID LOSS WAS IDENTIFIED AT THE CUFF BUT WAS ATTRIBUTED TO A CONNECTION ISSUE AT THE JUNCTION BETWEEN THE CUFF AND THE TUBING. THE PUMP WAS CONFIRMED TO DELIVER INCONSISTENT PRESSURE, EXHIBITED INTERMITTENT OPERATION, AND DIMPLING OF THE PUMP HOUSING WAS OBSERVED DESPITE PROPER SETUP AND HANDLING. THE PHYSICIAN SUSPECTED THAT THE PUMP NONFUNCTIONING WAS DUE TO MATERIAL FATIGUE OF THE PUMP HOUSING ASSOCIATED WITH THE OBSERVED DIMPLING. THE BALLOON WAS NOTED TO BE UNABLE TO MAINTAIN APPROPRIATE SYSTEM PRESSURE, WITH INFLATION AND DEFLATION ISSUES, AND APPEARED PARTIALLY DEFLATED. THE PHYSICIAN STATED THAT A SLOW LEAK OF THE BALLOON COULD NOT BE EXCLUDED. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLIC ATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 24689099 ↗
• InjuryFeb 5, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE WITH A NONFUNCTIONING DEVICE, PARTICULARLY WHEN CHANGING POSITION OR WHEN SITTING ON A CHAIR THAT WAS TOO LOW. A FIBROSCOPY REVEALED AN OVERLY WIDE CUFF IMPRINT; THEREFORE, A REVISION SURGERY WAS PERFORMED. EXAMINATION OF THE EX VIVO COMPONENTS SHOWED NO EVIDENCE OF LEAKAGE FROM THE CUFF, BALLOON, OR TUBING. PHYSICIAN SUSPECTED FROM A VALVE OR PRESSURE ISSUE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24274741 ↗
• InjuryJan 12, 2026Mechanical 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 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 24035288 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS EXPERIENCING RECURRENT URINARY INCONTINENCE. THE PATIENT REPORTED BREAKTHROUGH INCONTINENCE AFTER LONG-TERM USE OF THE DEVICE, AND TROUBLESHOOTING ATTEMPTS PERFORMED IN THE OFFICE WERE UNSUCCESSFUL. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE ENTIRE AUS SYSTEM WAS REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24021648 ↗
• InjuryDec 22, 2025Mechanical Problem; Nonstandard Device; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH DEVICE MALFUNCTION. THE CUFF REMAINED OPEN WITH NO RESPONSE TO PUMPING ATTEMPTS, AND THE SPHINCTER WAS NON-FUNCTIONAL. IMAGING SHOWED THE BALLOON HAD LOST ITS TYPICAL SHAPE. THE AUS WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873086 ↗
• InjuryDec 16, 2025Mechanical Problem; Inadequacy of Device Shape and/or Size; Mechanical Problem; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT URINARY INCONTINENCE, REQUIRING DAILY USE OF DIAPERS. THE PHYSICIAN INDICATED THAT THIS WAS LIKELY DUE TO A MECHANICAL PROBLEM OR URETHRAL ATROPHY. A SIZING ISSUE WITH THE CUFF WAS ALSO NOTED. A REVISION SURGERY HAS BEEN SCHEDULED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 23820994 ↗
• InjuryDec 15, 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 AN INFECTION. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 23804079 ↗
• InjuryDec 9, 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 CRACK 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 23760816 ↗
• InjuryNov 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 RECURRING INCONTINENCE, WHICH WAS INITIALLY BELIEVED TO BE DUE TO THE DEVICE NOT WORKING PROPERLY. HOWEVER, DURING A CYSTOSCOPY EXAMINATION, NO DEVICE RELATED ISSUES WERE IDENTIFIED; INSTEAD, URETHRAL EROSION WAS OBSERVED. AS A RESULT, THE AUS WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 23667612 ↗
• InjuryOct 23, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL BECAUSE HIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT FUNCTIONING PROPERLY. THE PATIENT UNDERWENT SURGERY TWO WEEKS LATER AND UPON INSPECTION, A CRACK WAS IDENTIFIED IN THE CUFF CONNECTING TUBE. ALL COMPONENTS WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369264 ↗
• MalfunctionOct 20, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH FLUID DISCHARGE, AND THE DEVICE WAS NOT WORKING AS EXPECTED. A REPLACEMENT SURGERY HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fluid Discharge; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344064 ↗
• InjuryOct 16, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCE RECURRING INCONTINENCE DUE TO THE DEVICE NO LONGER WORKING. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE AUS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23319340 ↗

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