AMS 800 Artificial Urinary Sphincter 72404135Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00878953003139), received between Apr 9, 2019 and Sep 15, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence. A surgical procedure was performed in which the cuff was explanted and replaced with a smaller cuff. There were no further patient complications reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50766219 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH NO DEVICE ISSUES WERE NOTED. THE CUFF WAS REMEASURED AND DOWNSIZED TO 4.5 CM. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 25162840 ↗
• InjuryApr 24, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE FOLLOWING THE INITIAL CUFF PLACEMENT. A CYSTOSCOPY WAS PERFORMED, AND THE URETHRA DID NOT SHOW ANY BLANCHING, SUGGESTING THAT THE CUFF MAY BE TOO LOOSE. A SURGICAL PROCEDURE WAS PERFORMED TO DOWNSIZE THE CUFF. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24986218 ↗
• InjuryApr 22, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT URINARY INCONTINENCE, REQUIRING THE USE OF TWO PADS PER DAY. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH CUFF MIGRATION WAS IDENTIFIED. THE CUFF WAS REMEASURED, AND A NEW 4.0 CM CUFF WAS PLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24960411 ↗
• InjuryDec 23, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) IMPLANT DEVICE WAS EXPERIENCING RECURRING INCONTINENCE. THE PHYSICIAN BELIEVES THE ORIGINAL CUFF WAS TOO LARGE AND LOOSE AROUND THE URETHRA, AND THIS WAS WHAT CONTRIBUTED TO THE RECURRING INCONTINENCE. A REVISION SURGERY WAS PERFORMED AT WHICH TIME THE ORIGINAL CUFF WAS EXPLANTED AND A NEW CUFF WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 23882590 ↗
• InjuryFeb 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE CUFF WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 21470048 ↗
• InjuryNov 5, 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 STATED THAT HE HAS NEVER BEEN FULLY CONTINENT AFTER SINCE IMPLANT PROCEDURE; THEREFORE, A REVISION SURGERY WAS PERFORMED TO REMOVE THE CUFF AND IMPLANT A SMALLER ONE. THERE WERE NO DEVICE ISSUES AND NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 20609831 ↗
• InjuryJun 10, 2024Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; 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) PRESENTED WITH RECURRING INCONTINENCE. THE ORIGINAL CUFF APPEARED TO BE TOO BIG. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATION REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 19499142 ↗
• InjuryMay 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS). A SURGERY PROCEDURE WAS PERFORMED DURING WHICH A FLUID LEAK WAS IDENTIFIED IN THE CUFF. ALL COMPONENTS WERE REMOVED AND REPLACED WITH NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 16857131 ↗
• InjuryFeb 11, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCONTINENCE SHORTLY AFTER THE ORIGINAL ARTIFICIAL URINARY SPHINCTER (AUS) IMPLANT PROCEDURE. A REVISION SURGERY WAS PERFORMED IN WHICH THE CUFF WAS REMOVED AND REPLACED WITH A SMALLER SIZE ONE. THE RESULTS OF THE PROCEDURE WERE POSITIVE.

  Patient problems: Urinary Incontinence

  MAUDE report 13514372 ↗
• InjuryAug 11, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REVISE THIS ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO RECURRING INCONTINENCE REQUIRING THE PATIENT TO USE 3 PADS PER DAY AND ATROPHY AS A RESULT OF THE CUFF BEING TOO LARGE FOR THE PATIENT. THE AUS 6.5CM CUFF WAS EXPLANTED AND DOWNSIZED TO AN AUS 5.5CM CUFF WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 12310163 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RECURRING INCONTINENCE HAS PERSISTED DESPITE OF ARTIFICIAL URINARY SPHINCTER (AUS) REVISIONS. A REVISION SURGERY WAS PERFORMED TO DOWNSIZE THE TRANSCORPORAL CUFF TO A 6.0 CM CUFF, ALTHOUGH THE DEVICE WAS FUNCTIONING AS EXPECTED. DURING SURGERY, A SMALL PERFORATION WAS MADE IN THE URETHRA, THOUGH PROXIMAL TO THE LOCATION OF THE CUFF. THE SURGEON REPAIRED THE URETHRAL DEFECT AND WAS WILLING TO PLACE THE NEW CUFF DESPITE OF THE URETHRAL DEFECT; AS HE BELIEVES THAT ANOTHER PERINEAL INCISION COULD NOT BE PERFORMED TO THIS PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Perforation; Urinary Incontinence

  MAUDE report 11440356 ↗
• InjuryApr 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ARTIFICIAL URINARY SPHINCTER (AUS) WAS EXPLANTED BECAUSE THE PATIENT BECAME INCONTINENT AGAIN. A NEW AUS DEVICE WAS IMPLANTED. THERE WERE NO FURTHER COMPLICATIONS. IT WAS FURTHER REPORTED THERE WAS FLUID LOSS FROM THE DEVICE.

  Patient problems: Incontinence

  MAUDE report 8496413 ↗

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