AMS 800 Artificial Urinary Sphincter 72400098Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 00878953000688), received between Oct 31, 2018 and Aug 12, 2026 — classified as 124 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (62 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 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.

Recalls naming this device

1. Oct 28, 2024Class IIOpen, Classified

   Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)

   Z-0530-2025 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Malposition of Device; Patient-Device Incompatibility

  It was reported that this Artificial Urinary Sphincter (AUS) pump was mispositioned in the patient's scrotum. It was believed that due to the patient's size, placing the pump lower would allow the patient to better access the pump. The patient later reported difficulty accessing the pump due to its location. As a result, the pump was explanted and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50217668 ↗
• InjuryJul 14, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. UPON EVALUATION OF THE CONTROL PUMP, NO PRESSURE WAS DETECTED, AND A POSSIBLE MINOR LEAK WAS SUSPECTED. SEVERAL DAYS LATER DURING A FOLLOW UP HOSPITAL VISIT, THE PHYSICIAN OBSERVED EROSION UPON EXAMINATION OF THE URETHRA. ENDOSCOPIC IMAGES WERE OBTAINED AND PROVIDED BY THE HOSPITAL. THE DEVICE REMAINS IMPLANTED AND A SURGERY REPLACEMENT IS PLANNED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 25821018 ↗
• InjuryMar 9, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED A MECHANICAL ISSUE INVOLVING THE PUMP SWITCH, WHICH DID NOT ALLOW THE PUMP TO REBOUND. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547063 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED WOUND DEHISCENCE, PAIN AT THE LEVEL OF THE PUMP, FLUID DISCHARGE, AND PARTIAL EXPOSURE OF THE DEVICE. AS A RESULT, THE PUMP WAS EXPLANTED AND REPOSITIONED IN A DIFFERENT LOCATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Fluid Discharge; Pain; Wound Dehiscence

  MAUDE report 24321507 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED CUTANEOUS EROSION AND EXPOSURE OF THE TUBING IN THE INGUINAL REGION, ALONG WITH A CUTANEOUS FISTULA REVEALING THE TUBING. AS A RESULT, THE PUMP WAS EXPLANTED, WHILE THE BALLOON AND CUFF WERE LEFT IN PLACE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Fistula

  MAUDE report 24321486 ↗
• InjuryDec 23, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; 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 PUMP CONNECTING TUBE WAS IDENTIFIED. ALL THE COMPONENTS WERE REMOVED AND REPLACED. THE CAUSE OF CRACK IN THE CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877356 ↗
• InjuryDec 22, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) RETURNED WITHOUT INITIAL REPORTER AND ANY PERFORMANCE ALLEGATION INFORMATION. UPON ANALYSIS OF THE RETURNED COMPONENTS, THE PUMP CLEAR TUBING HAD A HOLE, A FLUID LEAK WAS OBSERVED, AND PUMP FAILED POPPET PRESSURE TEST. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862538 ↗
• InjuryNov 19, 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) PRESENTED FOR A FOLLOW-UP SESSION, DURING WHICH A CYSTOSCOPY WAS PERFORMED. THE EXAMINATION REVEALED NO DEVICE-RELATED ISSUES. BLADDER FILLING WAS NORMAL, AND NO ABNORMALITIES OR SIGNS OF EROSION WERE OBSERVED DURING VAGINAL ENDOSCOPY. VAGINAL EXAMINATION SHOWED NO SUSPICIOUS FINDINGS, AND THERE WAS NO LEAKAGE DURING COUGHING OR STRAINING. A GRADE 1 RECTOCELE WAS NOTED, WITHOUT CYSTOCELE, AND PALPATION OF THE PUMP SITE ELICITED NO PAIN. DESPITE THIS, THE PATIENT HAD BEEN EXPERIENCING PAIN NEAR THE PUMP FOR SEVERAL WEEKS. ONE WEEK PRIOR TO ADMISSION, EDEMA AND INFLAMMATION DEVELOPED AT THE SITE, PROMPTING HER ATTENDING PHYSICIAN TO INITIATE ANTIBIOTIC THERAPY, WHICH INITIALLY LED TO CLINICAL IMPROVEMENT. HOWEVER, THE DAY BEFORE HOSPITALIZATION, THE PATIENT OBSERVED THAT THE PUMP HAD EXTERIORIZED THROUGH THE RIGHT LABIA MAJORA. CLINICAL EXAMINATION CONFIRMED THE EXTERIORIZATION OF THE PUMP THROUGH THE RIGHT LABIA MAJORA, WITH MILD SKIN INFLAMMATION AND NO PALPABLE RENITENT MASS. THE PATIENT WAS STABLE. LABORATORY FINDINGS INDICATED SIGNS OF INFECTION. A LOCALIZED INFECTION AT THE PUMP SITE, COMPLICATED BY EXT

  Patient problems: Erosion; Inflammation; Insufficient Information; Pain; Prolapse; Swelling/ Edema; Unspecified Infection

  MAUDE report 23597929 ↗
• InjuryNov 4, 2025Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) DEVICE EXPERIENCED RECURRING INCONTINENCE. IT WAS NOTED THAT THE PATIENT HAD THE DEVICE FOR 8 YEARS, AND THE PHYSICIAN FOUND THE URETHRA HAD SLIGHTLY NARROWED, WHICH LED TO THE DECISION TO REPLACE THE DEVICE. DURING THE PROCEDURE, THE DEVICE WAS EXPLANTED WITHOUT ANY COMPLICATIONS. AN ENDOSCOPIC EXAMINATION REVEALED THERE WERE NO SIGNIFICANT ISSUES, SO IT WAS DECIDED TO PROCEED WITH IMPLANTATION OF A NEW AUS DEVICE. AFTER SECURING THE ABDOMINAL SPACE, SIGNIFICANT BLEEDING OCCURRED WHILE ATTEMPTING TO SECURE THE URETHRAL SPACE. THE BLEEDING WAS CONTROLLED APPROXIMATELY TWO HOURS LATER. HOWEVER, DUE TO THE PATIENT'S CONDITION, THE PHYSICIAN DECIDED TO NOT IMPLANT A NEW AUS DEVICE. THE PATIENT IS CURRENTLY RECEIVING MEDICATION BASED TREATMENT TO ALLOW TIME FOR RECOVERY. THERE WERE NO FURTHER PATIENT COMPLICATIONS. THIS REPORT IS FOR THE BLEEDING AND ABORTED IMPLANT PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23468360 ↗
• InjuryOct 24, 2025Mechanical Problem; Material Puncture/Hole; Mechanical 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, A CRACK WAS FOUND IN THE PUMP CONNECTING TUBE, SO THE PUMP AND THE CUFF WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381148 ↗
• InjuryOct 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED MECHANICAL PROBLEM. THE IPP WAS REMOVED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378521 ↗
• InjurySep 18, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Urinary Incontinence

  MAUDE report 23092336 ↗
• InjuryAug 28, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. A LEAK WAS SUSPECTED, ALTHOUGH THE EXACT LOCATION WAS NOT IDENTIFIED. UPON EXPLANT, THE BALLOON WAS FOUND EMPTY AND THE PUMP CONTAINED AIR. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE ORIGINAL BALLOON, PUMP, AND CONNECTORS WERE REMOVED AND REPLACED, WHILE THE ORIGINAL CUFF WAS LEFT IN PLACE BUT DRAINED DUE TO EXTREME PROXIMAL PLACEMENT. A NEW CUFF WAS IMPLANTED MORE DISTALLY. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22918021 ↗
• InjuryAug 27, 2025Mechanical Problem; Difficult or Delayed Activation; Mechanical Problem; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) VISITED THE CLINIC FOR DEVICE ACTIVATION; HOWEVER, THE DEVICE DID NOT WORK. AS A RESULT, THE PATIENT CONTINUED TO EXPERIENCE RECURRENT URINARY INCONTINENCE. CLINICAL EXAMINATIONS CONFIRMED THAT THE PUMP DID NOT MAINTAIN THE OCCLUSIVE CUFF. NO VOIDING WAS OBSERVED, AND URODYNAMIC STUDIES STILL INDICATED INCONTINENCE. SEVERAL DAYS LATER, THE PATIENT CONTACTED THE CLINIC AND STATED THAT HE WOULD NOT BE UNDERGOING THE PROCEDURE WITH HIS PREVIOUS PHYSICIAN. HE IS CURRENTLY AWAITING DELIVERY OF THE REPLACEMENT DEVICE TO SCHEDULE THE PROCEDURE. THE DEVICE REMAINS IMPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22908169 ↗
• InjuryAug 7, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) WENT TO THE HOSPITAL BECAUSE THE PRODUCT DID NOT WORK PROPERLY. TWO WEEKS LATER, AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THERE WAS A CRACK IN THE PUMP CONNECTING TUBE, SO ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738382 ↗
• InjuryAug 4, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A CRACK IN THE PUMP CONNECTING TUBE WAS FOUND. THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709930 ↗
• InjuryJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. UPON REVISION, FLUID LOSS WAS OBSERVED AT THE TUBING RIGHT ABOVE THE PUMP; THEREFORE, THE AUS WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22543751 ↗
• InjuryJul 16, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) WENT TO THE HOSPITAL BECAUSE THE PRODUCT DID NOT WORK PROPERLY. TWO WEEKS LATER, AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THERE WAS A CRACK IN THE PUMP CONNECTING TUBE. ALL COMPONENTS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519805 ↗
• InjuryJul 15, 2025Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  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 THERE WAS A CRACK IN THE PUMP CONNECTING TUBE, SO THE PUMP AND A CUFF WERE REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516383 ↗
• InjuryMay 13, 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 WAS NOT CYCLING PROPERLY. ON (B)(6) 2025, A COMPUTED TOMOGRAPHY SHOWED THAT THE PRESSURE REGULATING BALLOON HAD A LOW VOLUME. URETHROCYSTOSCOPY WAS USED TO IDENTIFY THE INCOMPLETE OCCLUSION OF THE BULBAR URETHRA AT THE SITE OF IMPLANTATION OF THE CUFF. THE AUS IS STILL IMPLANTED; A REPLACEMENT SURGERY WILL BE PERFORMED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 22011849 ↗
• InjuryMay 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH A BULGE IN THE LOWER ABDOMEN, FROM WHICH PUS EMERGED. ADDITIONALLY, THE PUMP AREA WAS RED AND SWOLLEN; THEREFORE, A REMOVAL SURGERY WAS PERFORMED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Abscess; Erythema; Purulent Discharge; Swelling/ Edema

  MAUDE report 21949480 ↗
• InjuryApr 22, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER EXPERIENCED RECURRENT INCONTINENCE AND SWELLING IN THE GENITAL AREA. DURING THE OUTPATIENT VISIT, THE PHYSICIAN VERIFIED THAT THE CONTROL PUMP WAS RETAINED IN THE LOWER PART OF THE SCROTUM, AND UPON EXPOSURE, IT WAS COMPLETELY EXPOSED FROM THE SCROTUM. THE PHYSICIAN SCHEDULED A REMOVAL SURGERY FOR (B)(6) 2025. THE PHYSICIAN CONFIRMED THAT THE DEVICE WAS OPERATING NORMALLY, AND THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Erosion; Swelling/ Edema; Urinary Incontinence

  MAUDE report 21882716 ↗
• InjuryMar 20, 2025Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL DUE TO THE ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING PROPERLY. AFTER TWO WEEKS, A SURGICAL PROCEDURE WAS PERFORMED AND DURING INSPECTION, IT WAS NOTICED THERE WAS A CRACK IN THE PUMP CONNECTING TUBE. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652386 ↗
• InjuryFeb 18, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED URINARY RETENTION. THE PUMP WAS NOT WORKING AND WAS COLLAPSED. THE SUSPECTED CAUSE OF THE PUMP ISSUE IS FLUID LOSS. THE DEVICE IS STILL IMPLANTED. A REPLACEMENT SURGERY WILL BE PERFORMED ON (B)(6) 2025. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Retention

  MAUDE report 21393933 ↗
• InjuryJan 30, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) HAD A HERNIA. IT WAS NOTICED THAT THE PUMP WAS COMPLETELY EXTERNALIZED. THE ARTIFICIAL URINARY SPHINCTER (AUS) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Hernia

  MAUDE report 21275673 ↗

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-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