AMS 800 Artificial Urinary Sphincter 72404131Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,394 adverse event reports that list this exact device (DI 00878953003092), received between Sep 4, 2018 and Sep 30, 2026 — classified as 1,373 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (308 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 1,394 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fluid/Blood Leak

  Patient problems: Urinary Incontinence

  MAUDE report 50953784 ↗
• InjurySep 28, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. The device exhibited a fluid loss. A surgical procedure was performed, during which a small hole in the middle of the cuff was identified. As a result, the AUS was removed and replaced. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50917905 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematuria; Urinary Incontinence

  MAUDE report 50890354 ↗
• InjurySep 22, 2026Mechanical Problem; Inadequacy of Device Shape and/or Size

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence. A surgical procedure was performed to fully replace the AUS. It was determined that the recurring urinary incontinence was associated with the device length selected and device fatigue over time. No additional patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50856295 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported patient was experiencing retention, hematuria and UTI. As a result, the Artificial Urinary Sphincter (AUS) was explanted and replaced, a new 5.0 cm cuff was placed. No further patient complications were reported.

  Patient problems: Urinary Retention

  MAUDE report 50854173 ↗
• InjurySep 21, 2026Mechanical Problem

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) stated his device stopped functioning following implantation. The patient also stated he experienced pain. A surgical procedure was performed to remove the AUS. No additional information was provided.

  Patient problems: Pain

  MAUDE report 50843111 ↗
• InjurySep 18, 2026Mechanical Problem

  It was reported that the patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. According to the physician, the device was not fully coaptating around the urethra. A revision procedure was performed during which the existing 4.5 cm cuff was explanted and replaced with a 4.0 cm cuff. An additional cc of saline was added to improve cuff coaptation. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50813075 ↗
• InjurySep 17, 2026Mechanical Problem; Inadequacy of Device Shape and/or Size

  It was reported that this Artificial Urinary Sphincter (AUS) presented mechanical issues. Upon inspection, it was noted that the cuff was a little bit too big. 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 50802762 ↗
• InjurySep 16, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792207 ↗
• InjurySep 16, 2026Fluid/Blood Leak; Mechanical Problem

  Patient problems: Urinary Incontinence

  MAUDE report 50790752 ↗
• InjurySep 16, 2026Mechanical Problem

  It was reported that the patient was experiencing reoccurring incontinence with the Artificial Urinary Sphincter (AUS) after the patient was scoped. As a result, the device was explanted and replaced. No further patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50789368 ↗
• InjurySep 16, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) was experiencing recurring incontinence. Imaging identified that the pressure regulating balloon was empty, and during surgical evaluation a hole was identified in the pressure regulating balloon. The pressure regulating balloon was explanted and replaced, while the cuff and pump were examined and retained. There were no further patient complications reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50787951 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Artificial Urinary Sphincter (AUS) was experiencing incontinence. Upon revision, it was noticed that the cuff wasn't closing completely due to the urethra atrophy. No device issues were identified. As a result, the device was explanted and replaced. No further device complications were reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50777147 ↗
• InjurySep 11, 2026Fluid/Blood Leak

  It was reported that this Artificial Urinary Sphincter (AUS) presented fluid leak. 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 50735033 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Incontinence

  MAUDE report 50650666 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence, and the physician suspected urethral atrophy. The physician was able to cycle the device; however, upon performing a cystoscopy, the physician found that complete urethral coaptation was not occurring. As a result, the cuff was downsized from 4.5 cm to 4.0 cm, and adequate coaptation was visualized. No further patient complications were reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50507257 ↗
• InjuryAug 20, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  Patient problems: Urinary Incontinence

  MAUDE report 50360090 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. No device issue was reported. It was reported that urethral atrophy was identified. A revision procedure was performed during which the cuff was downsized. No further patient complications were reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50349131 ↗
• InjuryAug 19, 2026Inadequacy of Device Shape and/or Size

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence. A surgical procedure was performed to fully replaced the AUS. It was reported that the probable cause was device not functioning properly, possibly due to the cuff originally being too large. No additional patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50333746 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence. No device issue was reported. It was further reported that radiation-related changes and urethral atrophy were the suspected causes of the recurring incontinence, and the physician did not believe the device caused or contributed to the condition. A revision procedure was performed during which the device was explanted. No patient complications were reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50177264 ↗
• InjuryAug 5, 2026Mechanical Problem

  It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced cuff erosion, which rendered the device non functional. A surgical procedure was performed to remove and replace the AUS. No further patient complications were reported.

  Patient problems: Erosion

  MAUDE report 50145162 ↗
• InjuryAug 5, 2026Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  It was reported that this patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. A surgical procedure was performed during which the cuff was explanted, and a new smaller cuff was implanted in the same location in the urethra. There were no device issues, and no additional information was provided.

  Patient problems: Urinary Incontinence

  MAUDE report 50142211 ↗
• InjuryAug 5, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that the patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. A surgical procedure was performed, during which fluid loss was identified due to a hole in the balloon that was discovered when it was filled on the back table. The balloon and cuff were replaced. No additional patient complications were reported.

  Patient problems: Urinary Incontinence

  MAUDE report 50141208 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. During a surgical procedure, tissue atrophy was identified around the cuff site. The AUS was completely explanted and replaced. No additional patient complications were reported.

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50124381 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50114872 ↗

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-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-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