AMS 800 Artificial Urinary Sphincter 72404132Recalls & reported problems
Boston Scientific Corporation · Occlusive Cuff with InhibiZone · Class 3 · Implant
All models of AMS 800 Artificial Urinary Sphincter (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This AMS 800 artificial urinary sphincter is an implant used to control urinary incontinence. Of its 564 reports, 560 are injuries, and patients mention incontinence in 310 reports. Listed problems include fluid leaks in 112, cuffs of the wrong size in 110 and mechanical problems. Recent reports describe cuffs being downsized or replaced after recurring incontinence, and some describe erosion. There were no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 576
- Deaths reported
- 0
- Injuries reported
- 572
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 576 adverse event reports that list this exact device (DI 00878953003108), received between Oct 22, 2018 and Sep 30, 2026 — classified as 572 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (114 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem193
- Fluid/Blood Leak114
- Inadequacy of Device Shape and/or Size113
- Mechanical Problem103
- Insufficient Device Problem Information80
- Material Puncture/Hole61
- Malposition of Device11
- Defective Device7
Patient problems
- Urinary Incontinence318
- Unspecified Tissue Injury103
- No Clinical Signs, Symptoms or Conditions84
- Incontinence59
- Erosion46
- Tissue Damage18
- Unspecified Infection16
- No Known Impact Or Consequence To Patient14
Recent adverse event reports
The 25 most recent of 576 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Inadequacy of Device Shape and/or Size
Patient problems: Urinary Incontinence
MAUDE report 50953249 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50951306 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50937843 ↗InjurySep 29, 2026Material Puncture/Hole
It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. A surgical procedure was performed, during which a hole in the cuff was found. As a result, the cuff was removed and replaced. The hole was discovered when the physician took a string and fill the cuff. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50933396 ↗InjurySep 28, 2026Inadequacy of Device Shape and/or Size
Patient problems: Urinary Incontinence
MAUDE report 50918055 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Urinary Incontinence
MAUDE report 50916627 ↗InjurySep 18, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822423 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. As a result, the device was explanted and replaced. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50791520 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Tissue Injury
MAUDE report 50791213 ↗InjurySep 15, 2026Fluid/Blood Leak; Mechanical Problem
It was reported that an Artificial Urinary Sphincter (AUS) was not functioning correctly and exhibited fluid loss. 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 50773283 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50724670 ↗InjurySep 10, 2026Fluid/Blood Leak; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724622 ↗InjurySep 9, 2026Inadequacy of Device Shape and/or Size
Patient problems: Urinary Incontinence
MAUDE report 50702379 ↗InjurySep 8, 2026Material Puncture/Hole; Inadequacy of Device Shape and/or Size
Patient problems: Urinary Incontinence
MAUDE report 50677575 ↗InjurySep 4, 2026Inadequacy of Device Shape and/or Size
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50600542 ↗InjuryAug 31, 2026Insufficient Device Problem Information
It was reported that the patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence, which was believed to be related to urethral atrophy and the age of the device. A revision procedure was performed during which the entire artificial urinary sphincter (AUS) system was explanted and replaced with a new AUS system. At the patient's request, the existing inflatable penile prosthesis (IPP) system was also explanted. No patient complications were reported.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50515539 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this Artificial Urinary Sphincter (AUS) was working properly but the urethra atrophied. A surgical procedure was performed during which the cuff was explanted and replaced. No additional information was provided.
Patient problems: Muscle Weakness/Atrophy
MAUDE report 50360081 ↗InjuryAug 14, 2026Inadequacy of Device Shape and/or Size
It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. A surgical procedure was performed, during which the physician determined that the original cuff size was too large. Therefore, the cuff was downsized. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50245658 ↗InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. A surgical procedure was performed to remove and replace the AUS, and the cuff was downsized. The physician believed that possible urethral atrophy was the reason the patient required a smaller cuff. No further patient complications were reported.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50245609 ↗InjuryAug 11, 2026Inadequacy of Device Shape and/or Size
It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. It was determined that the cuff was too large for the patient. A surgical procedure was performed to downsize the cuff. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50209649 ↗InjuryAug 5, 2026Malposition of Device; Adverse Event Without Identified Device or Use Problem
It was reported that this Artificial Urinary Sphincter (AUS) had slight recurring incontinence but worked well regardless as there were no device issues. A surgical procedure was performed during which the cuff was explanted and replaced with a smaller cuff size. The patient was stable following the procedure, and no additional information was provided.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50143037 ↗InjuryJul 30, 2026Detachment of Device or Device Component
It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. The cuff became undone and therefore was not maintaining pressure on the urethra, resulting in recurrent urinary incontinence. A surgical procedure was performed, during which the 5.0 cm cuff was replaced with a 4.5 cm cuff. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50087320 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. A surgical procedure was performed during which the cuff size was reduced and the pump was repositioned. No device issues were reported. No additional patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50087094 ↗InjuryJul 13, 2026Fluid/Blood Leak; Mechanical Problem; Nonstandard Device; Material Puncture/Hole
IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED WORSENING URINARY INCONTINENCE. THE PUMP WAS NOT CYCLING, AND THE DEVICE EXHIBITED FLUID LOSS. DURING REVISION SURGERY, WHILE THE PATIENT WAS POSITIONED IN THE DORSAL LITHOTOMY POSITION, THE OUTLINE OF THE CUFF WAS VISIBLE IN THE PERINEUM, SUGGESTING INSUFFICIENT TISSUE COVERAGE OF THE CUFF. THE DEVICE WAS EXPLANTED, AND THE CUFF WAS FOUND TO HAVE A VISIBLE HOLE THAT WAS IDENTIFIED AS THE SOURCE OF THE FLUID LOSS, RESULTING IN THE REPORTED INCONTINENCE. A NEW AUS WAS IMPLANTED. THE PHYSICIAN SUSPECTED THAT THE RUPTURE MAY HAVE BEEN CAUSED BY PROLONGED SITTING OR BICYCLE RIDING, AS THE PATIENT WAS A CYCLIST. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 25806730 ↗InjuryJul 10, 2026Mechanical Problem
IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED IN WHICH PHYSICIAN EXPLANTED THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25786566 ↗
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, ClassifiedAMS Artificial Urinary Sphincter Control Pump
- Z-0531-2025 · Oct 28, 2024 · Open, ClassifiedAMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
- Z-2442-2019 · Jul 19, 2019 · TerminatedAMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
- Z-1280-2013 · Mar 1, 2013 · TerminatedAMS 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 · TerminatedAMS 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 · TerminatedAMS 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
Other Device, Incontinence, Mechanical/Hydraulic devices
- AMS 800 Artificial Urinary Sphincter 72404130Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic1 death1,803 reports
- AMS 800 Artificial Urinary Sphincter 72404131Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic1,394 reports
- AMS 800 Artificial Urinary Sphincter 72400024Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic1 recall1 death999 reports
- AMS 800 Artificial Urinary Sphincter 720157-01Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic591 reports
- AMS 800 Artificial Urinary Sphincter 72400160Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic487 reports
- AMS 800 Artificial Urinary Sphincter 72404127Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic443 reports
- AMS 800 Artificial Urinary Sphincter 72400161Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic358 reports
- AMS 800 Artificial Urinary Sphincter 72404133Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic220 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page