AMS 800 Artificial Urinary Sphincter 720066-01Recalls & reported problems
Boston Scientific Corporation · Accessory Kit Quick Connect Window Connectors (3 Straight, 2 Right Angle, 1 Y), Suture-Tie Connectors (3 Straight, 2 Right Angle, 1 Y), 8 Collets, 1 Collet Holder, 1 Cuff Sizer, 2 22-Gauge Blunt Tip Needles, 2 15-Gauge Blunt Tip Needles, 2 30 cm Lengths of Tubing · Class 3 · Implant
All models of AMS 800 Artificial Urinary Sphincter (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00878953004938), received between Jun 14, 2020 and Mar 12, 2025 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (2 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
- Mechanical Problem2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Component Missing1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Consequences Or Impact To Patient2
- Erosion1
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
- Unspecified Infection1
- Urinary Incontinence1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) ACCESSORY KIT WAS OPENED TO PREPARE FOR AN AUS PROCEDURE. UPON OPENING, THE NURSES DISCOVERED A HAIR INSIDE THE STERILE PACKAGE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21590258 ↗InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS ARTIFICIAL URINARY SPHINCTER (AUS) ON AN UNKNOWN DATE, DUE TO EROSION AND POTENTIAL INFECTION. AT A LATER DATE, THE PATIENT HAD A NEW AUS IMPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Erosion; Unspecified Infection
MAUDE report 13011630 ↗InjuryApr 16, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REVISE THIS ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO THE CUFF NOT FUNCTIONING AS A RESULT OF A CONNECTOR ISSUE CAUSING THE PATIENTS INCONTINENCE TO RETURN. THE AUS REMAINS IMPLANTED AND ACTIVE AND THE CUFF CONNECTOR WAS ADJUSTED. THERE WERE NO PATIENT COMPLICATIONS AND THE CUFF WAS FUNCTIONING FOLLOWING ACTIVATION.
Patient problems: Urinary Incontinence
MAUDE report 11677654 ↗InjuryNov 25, 2020Break; Break
IT WAS REPORTED THAT DURING AN ARTIFICIAL URINARY SPHINCTER (AUS) SURGERY THE Y-CONNECTOR WAS BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10900789 ↗MalfunctionAug 14, 2020Component Missing; Component Missing
IT WAS REPORTED THAT MEASURING TAPE WAS NOT PRESENT WHEN PACKAGE WAS OPENED.
Patient problems: No Patient Involvement
MAUDE report 10407687 ↗InjuryJun 14, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A SURGICAL PROCEDURE INVOLVING HIS ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO DEVICE PERFORMANCE ISSUES. QUICK CONNECTOR ISSUES WHERE OBSERVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10151539 ↗
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-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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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