AMS 800 Artificial Urinary Sphincter 72404127Recalls & reported problems

Summary

The FDA's MAUDE database contains 443 adverse event reports that list this exact device (DI 00878953003078), received between Oct 18, 2018 and Sep 29, 2026 — classified as 413 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (135 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 443 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Difficult or Delayed Activation; Migration; Air/Gas in Device

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50940074 ↗
• InjurySep 25, 2026Difficult or Delayed Activation; Material Deformation; Migration; Air/Gas in Device

  It was reported that this Artificial Urinary Sphincter (AUS) was difficult to activate at the activation appointment. Per the patient they had a fall before the appointment. A surgical procedure was performed during which the entire device was explanted and replaced. Upon explant the physician discovered that the pump had migrated and tubing was potentially twisted. It was also identified there was air in the pump, but the Pressure Regulating Balloon (PRB) was still fully inflated with fluid. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897726 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50891501 ↗
• InjurySep 23, 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 urethral erosion, and the cuff was previously explanted. The erosion was diagnosed by cystoscopy. A surgical procedure was performed in which the pump was explanted, while the pressure regulating balloon was drained and retained. There were no further patient complications reported.

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 50868660 ↗
• InjurySep 21, 2026Human-Device Interface Problem; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848671 ↗
• InjurySep 21, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848535 ↗
• InjurySep 21, 2026Malposition of Device

  It was reported that the patient complained of the pump placement of the Artificial Urinary Sphincter (AUS). As a result, the pump was explanted and replaced. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841536 ↗
• InjurySep 17, 2026Mechanical Problem

  It was reported that the patient implanted with this Artificial Urinary Sphincter (AUS) experienced recurrent incontinence approximately six months post-implantation and three months after device activation. The patient reported that the device was no longer functioning properly and that symptoms of incontinence had returned. During a clinical examination, it was determined that there was a potential device-related issue, and revision surgery was scheduled to investigate the cause. During the surgical procedure, after the pump was exposed, it was observed that saline was not returning from the pressure-regulating balloon to the pump as expected. Troubleshooting was performed; however, no cause could be identified. The saline volume within the balloon was measured and found to be 23 cc, consistent with the volume documented during the original implantation procedure. Based on this finding, it was initially concluded that the balloon was functioning properly. To minimize unnecessary component replacement, only the pump was explanted and replaced. The newly implanted pump was connected to the existing system, and the AUS was tested through three complete cycles. The system functioned

  Patient problems: Urinary Incontinence

  MAUDE report 50806220 ↗
• InjurySep 9, 2026Mechanical Problem; Difficult or Delayed Activation

  It was reported that the patient stated the Artificial Urinary Sphincter (AUS) device stopped functioning and that repeated attempts to cycle the pump did not open the cuff, resulting in an inability to empty the bladder. The patient reported experiencing urinary retention. The patient was advised to seek immediate evaluation by a physician and was provided contact information for local urologists. No revision procedure was reported at the time of the complaint. No further patient complications were reported.

  Patient problems: Urinary Retention

  MAUDE report 50693479 ↗
• InjuryAug 21, 2026Malposition of Device

  It was reported that a patient implanted with an Artificial Urinary Sphincter (AUS) was unable to activate the device due to the location of the pump, which caused discomfort during activation attempts. A revision procedure was performed, during which the pump position was confirmed to be the cause of the activation difficulty. The pump component was explanted and replaced during the procedure. No additional patient complications were reported.

  Patient problems: Discomfort

  MAUDE report 50364922 ↗
• InjuryAug 20, 2026Mechanical Problem

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) was unable to properly activate the device. Troubleshooting maneuvers were performed in the office; however, they were unsuccessful in resolving the issue. Therefore, a surgical procedure was performed, during which it was determined that the pump was not cycling properly, preventing the device from functioning as intended. During the same procedure, hardening was observed in the area surrounding the pump, raising suspicion of an infectious process, particularly given the patient's history of diabetes. As a result, the decision was made to explant the AUS in its entirety. Later, the surgical re implantation was performed, a new AUS was implanted. No additional patient complications were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50351081 ↗
• InjuryAug 17, 2026Migration; Air/Gas in Device

  It was reported that this Artificial Urinary Sphincter (AUS) pump component was too high up during the healing process and the patient could not reach the pump. A surgical procedure was performed during which the device was repositioned. Upon explant the physician identified an air bubble in the pump and there was no leak in the system. The physician suspected the air bubble was potentially attributed to the previous surgery during pump component preparation. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50288810 ↗
• InjuryAug 5, 2026Device Remains Activated; Human-Device Interface Problem

  It was reported that this Artificial Urinary Sphincter (AUS) experienced urinary retention. The cuff would not open when the pump was squeezed and subsequently deactivated. The Pressure Regulating Balloon (PRB) was filled correctly, the cuff was correctly size with no evidence of a hole in the system. A surgical procedure was performed during which the entire device was explanted and replaced. No additional information was provided.

  Patient problems: Urinary Retention

  MAUDE report 50142062 ↗
• InjuryAug 5, 2026Migration

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. During a surgical procedure, it was identified that the pump tubing had eroded through the urethral skin. As a result, the pump and balloon were explanted. The 4.5 cm cuff was left in situ to serve as a placeholder on the urethra. Subsequently, a second surgical procedure was performed during which the cuff was explanted, and a new AUS system was implanted. No additional patient complications were reported.

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 50141966 ↗
• InjuryJul 30, 2026Insufficient Device Problem Information

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced a hydrocele. As a result, the pump was repositioned in other side. No further patient complications were reported.

  Patient problems: Swelling/ Edema

  MAUDE report 50093864 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced an infection, and purulent drainage was reported from a hole in the scrotum at the location of the pump. During a revision surgery, the physician confirmed that the pump had eroded through the scrotal tissue and that drainage was present at the site. The pump was explanted and replaced, and a drain was placed. No additional information was provided.

  Patient problems: Erosion; Perforation; Purulent Discharge; Unspecified Infection

  MAUDE report 50061256 ↗
• InjuryJul 21, 2026Mechanical Problem

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. A surgical procedure was performed to readjust the pump. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 25893623 ↗
• InjuryJul 20, 2026Malposition of Device

  It was reported that a patient was dissatisfied with his Artificial Urinary Sphincter (AUS). The balloon and pump were found to be malpositioned. As a result, the entire device was removed and replaced, with the new device implanted in the appropriate anatomical position. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883944 ↗
• InjuryJul 16, 2026Migration

  It was reported that the patient with an Artificial Urinary Sphincter (AUS) experienced complete extrusion of the pump through the scrotal skin, resulting in the pump being completely outside the body. A surgical procedure was performed during which the AUS was explanted. It was decided to allow the patient to recover prior to determining whether reimplantation would be appropriate. No additional patient complications were reported.

  Patient problems: Erosion

  MAUDE report 25841620 ↗
• InjuryJul 14, 2026Migration

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) presented with a control pump that was inaccessible in the scrotum. A revision surgery was performed, during which the physician confirmed that the control pump had migrated from its intended implant location on the right side of the anterior scrotum to the right far dependent scrotum underneath the testicle, rendering it inaccessible to the patient. The control pump was explanted and replaced. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820982 ↗
• InjuryJul 9, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT WORKING PROPERLY. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25773989 ↗
• InjuryJun 23, 2026Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED URINARY INCONTINENCE AND THE PUMP WOULD STAY OPENED FOR A FEW SECONDS, CONFIRMED VIA CYSTOSCOPY. A SURGICAL PROCEDURE WAS PERFORMED, AND ALL COMPONENTS WERE EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 25602764 ↗
• InjuryJun 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED INFECTION. AS A RESULT, THE DEVICE WAS EXPLANTED. SEVERAL DAYS LATER, A NEW DEVICE WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25446934 ↗
• InjuryJun 4, 2026Mechanical Problem; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED DIFFICULTY OPERATING THE CONTROL PUMP. A SURGICAL INTERVENTION WAS SUBSEQUENTLY PERFORMED, DURING WHICH IT WAS DETERMINED THAT THE TUBING WAS WRAPPED AROUND THE PUMP'S DEACTIVATION BUTTON, PREVENTING BOTH THE PHYSICIAN AND THE PATIENT FROM DEACTIVATING THE DEVICE. IT WAS SUSPECTED THAT POST OPERATIVE MIGRATION OF THE PUMP WITHIN THE SCROTUM CAUSED THE TUBING TO OBSTRUCT THE DEACTIVATION BUTTON. THE PUMP WAS REMOVED AND A NEW PUMP WAS REPOSITIONED WITHIN THE PATIENT'S SCROTUM. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394949 ↗
• InjuryMay 22, 2026Fluid/Blood Leak; Mechanical Problem; Difficult or Delayed Activation; Human-Device Interface Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE AND PRESENTED WITH A NONFUNCTIONING DEVICE. DURING A REVISION SURGERY, THE PHYSICIAN CONFIRMED THAT THE DEVICE DID NOT COAPT. IT WAS REPORTED THAT THE PUMP REMAINED LOCKED AND DID NOT REFILL, WITH PUMP COLLAPSE DIMPLING OBSERVED, REPORTEDLY DUE TO A FLUID LEAK IN THE SYSTEM. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Incontinence

  MAUDE report 25256599 ↗

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