AMS 800 Artificial Urinary Sphincter 72404142Recalls & reported problems
Boston Scientific Corporation · Occlusive Cuff with InhibiZone · Class 3 · Implant
All models of AMS 800 Artificial Urinary Sphincter (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878953003184), received between Feb 5, 2026 and Sep 21, 2026 — classified as 2 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Urinary Incontinence2
- Erosion1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erosion; Urinary Incontinence
MAUDE report 50848917 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) IMPLANT DEVICE EXPERIENCED RECURRENT INCONTINENCE ATTRIBUTED TO TISSUE ATROPHY. THE AUS DEVICE HAD NO MALFUNCTION OR ISSUES. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PHYSICIAN EXPLANTED THE CUFF AND REPLACED IT WITH A DOWNSIZED CUFF. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Tissue Injury; Urinary Incontinence
MAUDE report 24274945 ↗
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, ClassifiedAMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
- Z-0530-2025 · Oct 28, 2024 · Open, ClassifiedAMS Artificial Urinary Sphincter Control Pump
- Z-2442-2019 · Jul 19, 2019 · TerminatedAMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
- 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-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-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 72404132Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic576 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
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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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