AMS 800 Artificial Urinary Sphincter 72400160Recalls & reported problems

Summary

The FDA's MAUDE database contains 487 adverse event reports that list this exact device (DI 00878953000718), received between Oct 3, 2018 and Sep 28, 2026 — classified as 444 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (151 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 487 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Mechanical Problem

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50917616 ↗
• InjurySep 22, 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 during which the existing device was explanted. There were no further patient complications reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50855197 ↗
• InjurySep 11, 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 crack found in the cuff connecting tube. 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 50733147 ↗
• InjurySep 11, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced a progressive recurrence of urinary incontinence. Clinical and endoscopic evaluation identified a mechanical issue with the device. A surgical procedure was performed in which the sphincter was explanted and replaced. Examination of the explanted components identified a perforation of the cuff. There were no further patient complications reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50731940 ↗
• InjurySep 10, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  Patient problems: Urinary Incontinence

  MAUDE report 50724644 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. The patient had a previously implanted double cuff AUS consisting of a 4.0 cm cuff and a 4.5 cm cuff. A surgical procedure was performed during which the cuffs, balloon, and control pump were explanted. The AUS system was replaced with a 4.0 cm cuff, a 61-70 balloon, and a new control pump. No additional patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50568998 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem; Migration

  It was reported that this patient with an Artificial Urinary Sphincter (AUS) experienced perineal pain in (b)(6) 2026. On clinical examination, the cuff was adherent to the skin, with a site of suppuration present. It should be noted that the patient had a medical history of transurethral resectin of the prostate (TURP) in 2021, a radical prostatectomy in 2018, radiotherapy in 2020, and laser urethrotomy for a stone located at the anastomosis site associated with a fistula at the cuff site in (b)(6) 2025. Given the clinical picture of erosion and infection of the device, the physician performed a surgical procedure during which the device was explanted and replaced. No additional information was provided.

  Patient problems: Adhesion(s); Erosion; Fistula; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 50209693 ↗
• InjuryAug 5, 2026Mechanical Problem

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence, and the device stopped functioning. A surgical procedure was performed to remove and replace the entire AUS system. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50143176 ↗
• InjuryJun 19, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE AND THE AUS WAS NOT FUNCTIONING PROPERLY BY NOT INFLATING. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THE REPORTED CAUSE OF THE CUFF NO LONGER FUNCTIONING PROPERLY WAS SUSPECTED TO BE ATROPHY. UPON EXPLANT THE SYSTEM STILL HAD FLUID AND NO LEAK WAS OBSERVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 25563181 ↗
• InjuryJun 12, 2026Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE AND THE DEVICE STOPPED WORKING. THE SUSPECTED CAUSE OF THE RETURNING OF INCONTINENCE AND THE DEVICE DEFICIENCY WAS REPORTED TO BE THE END OF THE DEVICES SERVICE LIFE. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE PHYSICIAN REPAIRED A FOSSA STRICTURE AND REMOVED ONLY THE CUFF TO AVOID EROSION, AS POSTOPERATIVE CATHETERIZATION WAS REQUIRED. ALL OTHER COMPONENTS LEFT IN PLACE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urethral Stenosis/Stricture; Urinary Incontinence

  MAUDE report 25486696 ↗
• InjuryJun 10, 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. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 25460990 ↗
• InjuryMay 20, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT FUNCTIONING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH A CRACK WAS FOUND IN THE CUFF CONNECTING TUBE. THE CUFF WAS REMOVED AND A NEW 3.5 CM CUFF WAS IMPLANTED; NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232702 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. THE DEVICE WAS DESCRIBED AS HAVING BEEN IMPLANTED FOR NUMEROUS YEARS. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS EXPLANTED AND REPLACED. FOLLOWING IMPLANTATION, CYSTOSCOPIC EVALUATION WAS PERFORMED AND THE NEW DEVICE FUNCTIONED AS EXPECTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 25218697 ↗
• InjuryMay 13, 2026Mechanical Problem; 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. THE CUFF WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161409 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE, PAIN AND CUFF INFECTION. AS A RESULT, THE PATIENT ELECTED TO HAVE THE DEVICE REMOVED WITHOUT THE INVOLVEMENT OR KNOWLEDGE OF A COMPANY REPRESENTATIVE. SEVERAL DAYS LATER, A NEW DEVICE WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Unspecified Infection; Urinary Incontinence

  MAUDE report 24941267 ↗
• InjuryApr 8, 2026Insufficient Device Problem Information

  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: Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 24824288 ↗
• InjuryMar 31, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. DURING A SURGICAL PROCEDURE, IT WAS DETERMINED THAT THE DEVICE WAS NO LONGER PROVIDING ADEQUATE COAPTATION DUE TO ITS AGE. THE AUS WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24744503 ↗
• InjuryMar 2, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE AND PRESENTED WITH A NONFUNCTIONING DEVICE. DURING REVISION SURGERY, THE PHYSICIAN CONFIRMED THE PRESENCE OF A FLUID LEAK WITHIN THE SYSTEM, AND THE SUSPECTED CAUSE OF THE FLUID LOSS WAS ATTRIBUTED TO THE AGE OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24483925 ↗
• InjuryFeb 5, 2026Mechanical Problem; Material Puncture/Hole

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273993 ↗
• InjuryJan 21, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED A CRACK IN THE CUFF CONNECTION TUBE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141478 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Urinary Incontinence

  MAUDE report 23959044 ↗
• InjuryDec 26, 2025Fluid/Blood Leak; Mechanical Problem; Decrease in Pressure; Inadequacy of Device Shape and/or Size; Fluid/Blood Leak; Mechanical Problem; Decrease in Pressure; Inadequacy of Device Shape and/or Size

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

  Patient problems: Urinary Incontinence

  MAUDE report 23897057 ↗
• InjuryDec 23, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT URINARY INCONTINENCE. CYSTOSCOPY REVEALED THAT THE CUFF REMAINED WIDELY OPEN AND WAS UNABLE TO PROVIDE ADEQUATE CONTINENCE AFTER REACTIVATION. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE SYSTEM WAS REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23877058 ↗
• InjuryDec 22, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT A CRACK WAS FOUND IN THE CUFF CONNECTING TUBE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873687 ↗
• InjuryDec 16, 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) EXPERIENCED RECURRING INCONTINENCE DUE TO URETHRAL ATROPHY. ADDITIONALLY, IT WAS NOTED THAT THE CUFF BECAME TOO LARGE FOLLOWING THE ATROPHY. A REVISION SURGERY HAS BEEN REQUESTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 23822352 ↗

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