AMS 800 Artificial Urinary Sphincter 72400025Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00878953000633), received between Jan 7, 2019 and Sep 10, 2026 — classified as 26 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 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Fluid/Blood Leak

  It was reported that the patient was still experiencing incontinence of the Artificial Urinary Sphincter (AUS). A revision surgery was performed where the pump and balloon were explanted and replaced. During surgery, it was noticed that the balloon had no fluid left. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50713919 ↗
• InjuryJul 30, 2026Fluid/Blood Leak

  It was reported that the patient implanted with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. During a surgical revision procedure, fluid loss within the AUS system was identified. As a result, the AUS was explanted and replaced. It was also reported that the patient previously had a double cuff configuration, which was revised to a single cuff configuration during the replacement procedure and a 71-80 balloon. No additional patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50087897 ↗
• InjuryMay 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE. DURING REVISION SURGERY, THE PHYSICIAN CONFIRMED THAT THE PRESSURE REGULATING BALLOON (PRB) WAS EMPTY. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 25131075 ↗
• InjuryFeb 27, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH RECURRING INCONTINENCE, A FLUID LOSS IN THE DEVICE WAS REPORTED, UPON EXPLANATION, A RIP IN THE TUBING NEXT TO BE BALLOON WAS OBSERVED. THE AUS WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24471428 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT URINARY INCONTINENCE. A CYSTOSCOPY WAS PERFORMED AND REVEALED CUFF EROSION, POSSIBLY RELATED TO CATHETERIZATION DURING A RECENT HOSPITALIZATION. AS A RESULT, THE DEVICE WAS EXPLANTED, AND THE PATIENT WAS DISCHARGED WITH A FOLEY CATHETER TO ALLOW THE URETHRA TO HEAL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 24291734 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT URINARY INCONTINENCE AND ATROPHY. AS A RESULT, THE DEVICE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 23995135 ↗
• InjuryDec 23, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED RECURRING INCONTINENCE, IT WAS REPORTED THAT THE DEVICE PRESENTED A MECHANICAL PROBLEM. THE BALLOON WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23881666 ↗
• InjuryDec 17, 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 RECURRENT INCONTINENCE. DURING A REVISION SURGERY, THE PHYSICIAN SUSPECTED ATROPHY AND THEREFORE DOWNSIZED AND REPLACED THE CUFF FROM 4.0 CM TO 3.5 CM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 23835161 ↗
• InjuryJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED RECURRING INCONTINENCE. IT WAS DETERMINED THERE WAS AN OSMOTIC LEAK IN THE BALLOON. THE BALLOON WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22294288 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) SURGERY BECAUSE WAS DISSATISFIED WITH THE DEVICE. UPON REVISION, POSSIBLE SIGNS OF EROSION WERE FOUND; THEREFORE, THE AUS WAS REMOVED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 22159387 ↗
• InjuryJun 4, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. THE DEVICE HAD FLUID LOSS, AND IT WAS SUSPECTED AN ISSUE WITH THE PUMP AND THE FLOW. THE AUS WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22142537 ↗
• InjuryJan 23, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. ADDITIONALLY, THE DEVICE STOPPED WORKING, THE PHYSICIAN SUSPECTED A FLUID LOSS; THEREFORE, THE EXISTING AUS WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 21217488 ↗
• InjuryDec 12, 2024Adverse 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 HIS ARTIFICIAL URINARY SPHINCTER (AUS). THE PHYSICIAN SCOPED THE PATIENT AND NO ANOMALIES WERE OBSERVED IN THE FUNCTIONALITY OF THE AUS. THE PATIENT UNDERWENT SURGERY TO REPLACE THE BALLOON. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 20916073 ↗
• InjuryAug 14, 2024Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH RECURRENT URINARY INCONTINENCE. THE CUFF AND BALLOON WERE REPLACED, AND THE PHYSICIAN FOUND THE DEVICE HAD A FLUID LEAK. THERE WAS NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 19984443 ↗
• InjuryJul 9, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT CYCLING AS EXPECTED DUE TO FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED WHEREIN THE BALLOON COMPONENT WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707696 ↗
• InjuryJun 24, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE ARTIFICIAL URINARY SPHINCTER (AUS) BALLOON WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING URETHRAL PAIN. THE BALLOON WAS REMOVED AND REPLACED WITH A LOWER PRESSURE BALLOON. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 19601621 ↗
• InjuryJun 18, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE. IT WAS ALSO NOTED THAT HIS URINE STREAM HAD DECREASED TO A DRIBBLE. HE NOTED THAT HIS DEVICE HAD RECENTLY STOPPED WORKING. THE PUMP FEELS EXTREMELY HARD AND WILL NOT DEPRESS. THE PATIENT PRESENTED AT HIS CLINIC AND WAS DIRECTED TO GO TO THE EMERGENCY ROOM (ER) AS HE COULD NOT BE SEEN IN CLINIC FOR A MONTH. THE PATIENT SERVICES CONSULTANT DISCUSSED POTENTIAL DEVICE DEACTIVATION AND ALSO REFERRED HIM TO THE ER DUE TO POSSIBLE URINARY RETENTION. NO ADDITIONAL PATIENT COMPLICATION WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 19555658 ↗
• InjuryMar 28, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE DUE TO FLUID LEAKAGE CAUSED BY A HOLE IN THE PUMP TUBING. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 18998223 ↗
• InjuryJan 22, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED URINARY INCONTINENCE. A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION FLUID LEAKAGE DUE TO A HOLE IN THE BALLOON WAS FOUND. THE BALLOON WAS EXPLANTED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 18553827 ↗
• InjuryOct 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) REPLACEMENT SURGERY AS THE PATIENT WAS EXPERIENCING RECURRING INCONTINENCE. ALL THE COMPONENTS WERE REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 17913639 ↗
• InjurySep 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE WITH HIS ARTIFICIAL URINARY SPHINCTER (AUS). THE PATIENT UNDERWENT SURGERY TO REMOVE AND REPLACE THE BALLOON AND CUFF. THE EXPLANTED BALLOON EXHIBITED A FLUID LEAK. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 17764578 ↗
• InjuryOct 14, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REVISE AN ARTIFICIAL URINARY SPHINCTER (AUS) BALLOON DUE TO FLUID LEAK FROM A HOLE IN THE BALLOON. THE PATIENT WAS INCONTINENT AND HAD SOME PAIN IN THE SCROTUM AND ABDOMEN. A PATIENT OUTCOME OF FULLY RECOVERED WAS REPORTED.

  Patient problems: Abdominal Pain; Pain; Urinary Incontinence

  MAUDE report 12634562 ↗
• InjuryOct 13, 2020Migration; Migration

  IT WAS REPORTED THAT TUBING CONNECTOR HAD MIGRATED UP TO JUST BELOW SKIN LEVEL. THE PATIENT COULD FEEL THE CONNECTOR THAT WAS RIGHT BELOW HIS SKIN; AND THE DOCTOR WAS WORRIED THAT THE CONNECTOR MIGHT EVENTUALLY HERNIATE OUT THROUGH THE SKIN. BALLOON WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670358 ↗
• InjuryMay 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE TUBING OF THE ARTIFICIAL URINARY SPHINCTER (AUS) PRESSURE REGULATING BALLOON (PRB), POKED THROUGH THE SKIN IN THE PATIENT ABDOMEN. THE PRB WAS EXPLANTED AND REPLACED.

  Patient problems: Erosion

  MAUDE report 10036927 ↗
• InjuryNov 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT DEVELOPED A SCROTAL CYST FOR REASONS NOT RELATED TO THE IMPLANT. PHYSICIAN WAS CONCERNED WITH URETHRAL EROSION DEVELOPING AND DECIDED TO REMOVE THE IMPLANT AND LET THE PATIENT HEAL. ALL COMPONENTS OF EXISTING ARTIFICIAL URINARY SPHINCTER (AUS) WERE EXPLANTED. NO ADVERSE PATIENT EFFECTS.

  Patient problems: Erosion

  MAUDE report 9362227 ↗

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