AMS 800 Artificial Urinary Sphincter 72400162Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00878953000732), received between Oct 19, 2018 and Sep 30, 2026 — classified as 105 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (37 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 111 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Mechanical Problem; Material Puncture/Hole

  Patient problems: Urinary Incontinence

  MAUDE report 50952854 ↗
• InjurySep 30, 2026Material Puncture/Hole

  It was reported that this Artificial Urinary Sphincter (AUS) was not functioning properly. Upon inspection, a crack was found in the pump 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 50947547 ↗
• InjuryApr 23, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT'S ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT FUNCTIONING PROPERLY. THE CUFF WAS REMOVED AND UPON INSPECTION, A CRACK IN THE CUFF CONNECTING TUBE WAS OBSERVED. THE CUFF WAS THEN REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968307 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS EXPERIENCING RECURRENT INCONTINENCE FOLLOWING PRIOR REVISIONS. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE PUMP AND CUFF WERE EXPLANTED AND REPLACED WITH NEW COMPONENTS. THE EXPLANTED COMPONENTS WERE REPORTED TO BE INTACT WITH NO IDENTIFIED DEVICE ISSUES, AND POSSIBLE URETHRAL ATROPHY WAS CONSIDERED AS A CONTRIBUTING FACTOR. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 24401768 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH PROGRESSIVE URINARY OBSTRUCTION. ENDOSCOPY REVEALED EXTENSIVE URETHRAL EROSION ALONG THE ANTERIOR WALL WITH INTRUSION OF THE CUFF. THE AUS WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Erosion; Urinary Retention

  MAUDE report 24260752 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED A PROGRESSIVE DECREASE IN URINARY FLOW, WHICH WORSENED TO DRIBBLING URINATION. ENDOSCOPIC EVALUATION REVEALED URETHRAL EROSION ASSOCIATED WITH THE AUS CUFF, EXTENDING ALONG THE ANTERIOR URETHRAL SURFACE, WITH ASSOCIATED OBSTRUCTIVE VOIDING DIFFICULTIES. THE DEVICE WAS DEACTIVATED, AND A URINARY CATHETER WAS PLACED. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE AUS WAS COMPLETELY REMOVED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Urinary Retention

  MAUDE report 24233252 ↗
• InjuryJan 27, 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 THAT THE CUFF HAD A HOLE, SO THE CUFF WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194533 ↗
• InjuryJan 14, 2026Mechanical Problem

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

  Patient problems: Urinary Incontinence

  MAUDE report 24076807 ↗
• InjuryJan 7, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) WENT TO THE HOSPITAL BECAUSE THE PRODUCT WAS NOT WORKING PROPERLY. TWO WEEKS LATER UPON INSPECTION, IT WAS CONFIRMED THAT THE CUFF HAD A HOLE, SO THE CUFF WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995678 ↗
• InjuryDec 8, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE WENT TO THE CLINIC BECAUSE THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE CUFF CONNECTING TUBE WAS IDENTIFIED. THE CAUSE OF CRACK IN THE CUFF CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. THE CUFF WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743488 ↗
• InjuryDec 1, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT FUNCTIONING PROPERLY. DURING THE SURGICAL PROCEDURE, A CRACK WAS IDENTIFIED IN THE CUFF CONNECTING TUBE. THE CUFF WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23686462 ↗
• InjuryNov 20, 2025Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS), EXHIBITED MULTIPLE DEVICE ISSUES. THE PUMP WAS COLLAPSED AND DEMONSTRATED INCREASED RESISTANCE DURING ACTIVATION, LIKELY DUE TO AN INTERNAL MECHANICAL ISSUE. FLUID LOSS WAS OBSERVED IN THE PUMP AND THE BALLOON, FOR WHICH A PERFORATION AND A CONNECTOR-RELATED LEAK WERE SUSPECTED IN EACH COMPONENT. ADDITIONALLY, A HOLE IN THE CUFF WAS NOTED, WHICH MAY HAVE RESULTED FROM MATERIAL FATIGUE OR LOCALIZED STRESS ON THE COMPONENT OVER TIME. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE AUS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612560 ↗
• InjuryOct 15, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE WENT TO THE CLINIC BECAUSE THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE CUFF CONNECTING TUBE WAS IDENTIFIED. THE CAUSE OF CRACK IN THE CUFF CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. THE CUFF WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306420 ↗
• MalfunctionSep 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED SIGNIFICANT URINARY INCONTINENCE AFTER IMPLANTATION. IMAGING REVEALED THAT THE PRESSURE-REGULATING BALLOON CONTAINED LESS FLUID THAN EXPECTED. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23184262 ↗
• InjuryAug 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO THE DEVICE WAS OLD AND IT WAS NOT WORKING, DURING SURGERY IT WAS REPORTED EROSION AT THE CUFF SITE. THE AUS WAS EXPLANTED, THE PHYSICIAN DECIDED NOT TO PLACE A NEW CUFF AT THIS TIME AND ALLOW THE URETHRA TO HEAL COMPLETELY. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Erosion

  MAUDE report 22811875 ↗
• InjuryJun 30, 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) DEVELOPED URETHRAL EROSION, WHICH LED TO THE REMOVAL OF THE CUFF AND SCROTAL PUMP. THE PATIENT IS CURRENTLY EXPERIENCING SEVERE INCONTINENCE AND IS USING UP TO FIVE DIAPERS PER DAY. A NEW AUS IMPLANTATION IS BEING PLANNED ONCE THE PATIENT IS CLINICALLY ELIGIBLE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Dysuria; Erosion; Urinary Incontinence

  MAUDE report 22367195 ↗
• InjuryMay 30, 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 URETHRAL ATROPHY. THE AUS WAS EXPLANTED AND REPLACED WITH AN ADDITIONAL CUFF. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22116990 ↗
• InjuryMar 26, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED RECURRING INCONTINENCE, IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING DUE TO A FLUID LOSS. THE AUS WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 21701363 ↗
• InjuryFeb 26, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC BECAUSE THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE CUFF CONNECTING TUBE WAS IDENTIFIED. THE CAUSE OF CRACK IN THE CUFF CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. ALL THE COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468476 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CLINICAL EXAMINATION, THE PUMP PRESENTED PRE-EROSIVE SKIN AND SOME PUS. IT WAS ALSO FOUND EROSION NEAR THE ARTIFICIAL URINARY SPHINCTER (AUS) CUFF. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE AUS. THERE WAS NO REPORT OF SUSPICIOUS LESION IN THE BLADDER. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS COMPLAINT IS FOR THE THIRD DEVICE EXPLANTED IN 2025.

  Patient problems: Erosion; Purulent Discharge

  MAUDE report 21406787 ↗
• InjuryOct 22, 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 (AUS) EXPERIENCED INFECTION AT THE CUFF. THE AUS WAS EXPLANTED AND LATER REPLACED ON ANOTHER DATE. THERE WERE NO DEVICE ISSUES AND NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 20506110 ↗
• InjurySep 27, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL BECAUSE THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH A CRACK IN THE CUFF CONNECTING TUBE WAS FOUND. THE CUFF WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321915 ↗
• InjuryAug 14, 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 (AUS) PRESENTED WITH INFECTION DUE TO CUFF EROSION AND SWELLING IN THE SCROTUM AT THE INCISION SITE. THE AUS WAS REMOVED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.

  Patient problems: Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 19981646 ↗
• InjuryAug 5, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL BECAUSE THE ARTIFICIAL URINARY SPHINCTER WAS NOT PERFORMING AS EXPECTED. THE PATIENT UNDERWENT SURGERY TWO WEEKS LATER AND INSPECTION CONFIRMED A HOLE IN THE CUFF. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912198 ↗
• InjuryJul 31, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING PROPERLY DUE TO A CRACK IN THE CUFF CONNECTING TUBE. THE AUS CUFF WAS REPLACED, AND THERE WAS NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 19875235 ↗

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