AMS 800 Artificial Urinary Sphincter 72400024Recalls & reported problems

Summary

The FDA's MAUDE database contains 999 adverse event reports that list this exact device (DI 00878953000626), received between Oct 12, 2018 and Sep 30, 2026 — classified as 1 death, 961 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (446 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-0531-2025 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 999 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fluid/Blood Leak; Material Puncture/Hole; Human-Device Interface Problem

  Patient problems: Urinary Incontinence

  MAUDE report 50954927 ↗
• InjurySep 29, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. The patient stated that the device stopped functioning. A surgical procedure was performed, during which a small hole was found at the neck of the balloon, which caused a fluid loss. As a result, the AUS was removed. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933268 ↗
• InjurySep 29, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that the patient was experiencing incontinence with the Artificial Urinary Sphincter (AUS). Upon inspection, fluid loss and a hole in the balloon was noticed. As a result, the device was explanted and replaced with a higher-pressure balloon. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50932836 ↗
• InjurySep 28, 2026Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914814 ↗
• InjurySep 25, 2026Insufficient Device Problem Information

  Patient problems: Urinary Incontinence

  MAUDE report 50903843 ↗
• InjurySep 25, 2026Malposition of Device

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. Following cystoscopic evaluation, the pressure regulating balloon was observed to be malpositioned, appearing to be located in the bowel. A surgical procedure was performed in which the existing device was explanted. There were no further patient complications reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50893173 ↗
• InjurySep 24, 2026Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device

  Patient problems: Urinary Incontinence

  MAUDE report 50890350 ↗
• InjurySep 22, 2026Fluid/Blood Leak

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) complained about the functioning of the device. The physician ordered imaging, which confirmed that the balloon contained 17 cc of fluid. This could possibly indicate a fluid leak; however, this was not confirmed by the physician. The physician added 5 cc of saline and will reassess the patient to determine whether a complete revision is necessary. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854825 ↗
• InjurySep 21, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Air/Gas in Device

  Patient problems: Urinary Incontinence

  MAUDE report 50848706 ↗
• InjurySep 21, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  Patient problems: Urinary Incontinence

  MAUDE report 50848537 ↗
• InjurySep 21, 2026Fluid/Blood Leak; Mechanical Problem; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848021 ↗
• InjurySep 21, 2026Migration

  It was reported that the patient was experiencing incontinence with the Artificial Urinary Sphincter (AUS). Upon revision it was noted that balloon had herniated out of space into subconscious tissue. As a result, balloon was explanted and replaced in the Perry vesicle space. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50839938 ↗
• InjurySep 18, 2026Mechanical Problem

  It was reported that this Artificial Urinary Sphincter (AUS) presented a mechanical issue, as the pump was suspected to be locked and unable to activate the device. Upon evaluation, the concern was attributed to the balloon rather than the pump. The balloon was explanted and replaced. No additional information was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819039 ↗
• InjurySep 17, 2026Fluid/Blood Leak

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. Imaging identified less or no fluid in the pressure regulating balloon; however, the source of the leak was unknown, as the device was not tested on the back table. A surgical procedure was performed in which the existing AUS was explanted and replaced. There were no further patient complications reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50804962 ↗
• InjurySep 17, 2026Mechanical 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 hole in the balloon was identified. The cause of the hole was not detailed by the hospital. All the components were removed and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803529 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced erosion in the Pressure Regulating Balloon (PRB). As a result, the device was explanted. No further patient complications were reported.

  Patient problems: Erosion

  MAUDE report 50788571 ↗
• InjurySep 15, 2026Mechanical Problem

  It was reported that the patient started experiencing recurring incontinence with the Artificial Urinary Sphincter (AUS). Physician suspects the balloon lost elasticity. As a result, the device was explanted and replaced. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50775559 ↗
• InjurySep 15, 2026Mechanical Problem

  It was reported that an Artificial Urinary Sphincter (AUS) stopped functioning. A surgical procedure was performed to remove the Artificial Urinary Sphincter (AUS). No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772220 ↗
• InjurySep 11, 2026Mechanical Problem

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. Intraoperatively, the physician inspected the device, and all components appeared to be functioning properly. The patient rides motorcycles, and the physician suspected that this may have contributed to the device issue. The device was removed and replaced. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50725312 ↗
• InjurySep 11, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that the patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. During revision surgery, the pressure regulating balloon (PRB) was identified to have a fluid loss, and a pinhole was observed near the PRB hub during back-table testing. A revision procedure was performed during which the PRB was explanted and replaced with a new one. No patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50725285 ↗
• InjurySep 10, 2026Migration

  It was reported that the balloon of an Artificial Urinary Sphincter (AUS) had herniated from the space of Retzius into the subcutaneous tissue, just beneath the skin and superior to the space of Retzius. A surgical procedure was performed to remove the balloon and replace it with a new one in the appropriate anatomical position. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716540 ↗
• InjurySep 10, 2026Fluid/Blood Leak

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence following activation of the device. The physician scanned the balloon and found that there was no fluid in it. A surgical procedure was performed to remove and replace the balloon. The explanted balloon was tested; however, no holes or leaks were identified. The new device was tested and it was found that the urethra was adequately coapted and the patient was continent. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50716256 ↗
• InjurySep 9, 2026Migration

  It was reported that the patient with an Artificial Urinary Sphincter (AUS) experienced incontinence. Evaluation revealed that the pump had migrated superiorly within the scrotum, the balloon had migrated from the space of Retzius into the inguinal canal, and slight urethral atrophy was present. A revision procedure was performed during which the device was explanted and replaced with a new AUS. A smaller size cuff was implanted. No further patient complications were reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50693704 ↗
• InjurySep 9, 2026Migration

  It was reported that the patient's Artificial Urinary Sphincter (AUS) exhibited pump migration. During clinical evaluation, it was determined that the balloon was exerting tension on the pump, causing it to migrate. A revision procedure was performed to reposition the balloon. No additional device issues were identified. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692351 ↗
• InjurySep 8, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that the patient implanted with this Artificial Urinary Sphincter (AUS) experienced recurrent incontinence. A surgical procedure was performed, during which fluid loss within the system was identified. The source of the fluid leak was suspected to be the balloon, as this component was found to be devoid of fluid and a hole was observed in the balloon. The AUS was completely replaced. No additional patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50675392 ↗

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-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