AMS 800 Artificial Urinary Sphincter 72404133Recalls & 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 from Boston Scientific is an implanted device used to treat urinary incontinence. Its 221 reports, 216 of them injuries, often describe recurring incontinence, cuffs of the wrong size, and mechanical problems or fluid leaks that led to replacement surgery. There were no deaths. 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
- 220
- Deaths reported
- 0
- Injuries reported
- 215
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 00878953003115), received between Oct 12, 2018 and Sep 30, 2026 — classified as 215 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (61 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 Problem68
- Inadequacy of Device Shape and/or Size61
- Mechanical Problem42
- Fluid/Blood Leak31
- Insufficient Device Problem Information28
- Material Puncture/Hole15
- Defective Device7
- Inflation Problem5
Patient problems
- Urinary Incontinence145
- Unspecified Tissue Injury40
- Incontinence25
- No Clinical Signs, Symptoms or Conditions19
- Erosion11
- Unspecified Infection7
- Urinary Retention6
- No Known Impact Or Consequence To Patient5
Recent adverse event reports
The 25 most recent of 220 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 50948243 ↗InjurySep 22, 2026Inadequacy of Device Shape and/or Size
Patient problems: Urinary Incontinence
MAUDE report 50860414 ↗InjurySep 14, 2026Mechanical Problem
It was reported that patient was experiencing incontinence again. A s a result, his Artificial Urinary Sphincter (AUS) was explanted and replaced. The cuff was lowered from size 5.5cm to 5cm, and a higher-pressure regulator balloon was implanted. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50758748 ↗InjuryAug 13, 2026Inadequacy of Device Shape and/or Size
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence and the device had a size issue. As a result, the device was explanted and replaced. A smaller cuff was implanted. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50243516 ↗InjuryAug 11, 2026Insufficient Device Problem Information
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence. A surgical procedure was performed during which the cuff was downsized, and the pump was replaced and repositioned. There were no further patient complications reported.
Patient problems: Urinary Incontinence
MAUDE report 50213561 ↗InjuryAug 11, 2026Nonstandard Device
It was reported that the patient implanted with this Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. During cystoscopy, it was observed that the cuff was not fully coapting the urethra. A surgical revision procedure was subsequently performed, during which no device issues were identified. The AUS was explanted and replaced. The physician selected a more proximal location than the original cuff site and implanted a new 5.0 cm cuff. No additional patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50211008 ↗InjuryAug 11, 2026Insufficient Device Problem Information
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence. A surgical procedure was performed during which the existing device was explanted and replaced with a new AUS. There were no further patient complications reported
Patient problems: Urinary Incontinence
MAUDE report 50209690 ↗InjuryJun 23, 2026Nonstandard Device; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) SURGERY DUE TO UNSPECIFIED REASONS. NO ADDITIONAL INFORMATION WAS REPORTED. THE DEVICE WAS RETURNED AND THE DEVICE ANALYSIS REVEALED THAT THIS DEVICE DID NOT PASS ALL TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25600515 ↗InjuryJun 17, 2026Fluid/Blood Leak; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE AND PRESENTED WITH A NONFUNCTIONING DEVICE. DURING A REVISION SURGERY, THE PHYSICIAN CONFIRMED FLUID LOSS IN THE SYSTEM. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.
Patient problems: Urinary Incontinence
MAUDE report 25541736 ↗InjuryApr 14, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE AUS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 24879721 ↗InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH RECURRING INCONTINENCE AND BULBAR ATROPHY. THE AUS WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.
Patient problems: Unspecified Tissue Injury; Urinary Incontinence
MAUDE report 24845910 ↗InjuryApr 7, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH RECURRING INCONTINENCE, THE DEVICE PRESENTED A FLUID LOSS. THE PHYSICIAN REPORTED URETHRAL ATROPHY. THE AUS WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.
Patient problems: Unspecified Tissue Injury; Urinary Incontinence
MAUDE report 24802217 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH NO DEVICE ISSUES WERE IDENTIFIED. THE AUS CUFF WAS REPLACED, AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 24708686 ↗InjuryMar 16, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THIS PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. THE DEVICE WAS CYCLING BUT PRESUMABLY IT WAS NOT COAPTING THE URETHRA ENOUGH; THE PHYSICIAN BELIEVED THE CUFF WAS NO LONGER THE CORRECT SIZE FOR THE PATIENT. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 24613384 ↗InjuryFeb 25, 2026Inadequacy of Device Shape and/or Size; Malposition of Device
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. THE PHYSICIAN STATED THAT THE CUFF DID NOT ACHIEVE ADEQUATE URETHRAL COMPRESSION AND NOTED THAT THE BALLOON WAS POSITIONED VERY DEEP WITHIN THE RETROPUBIC SPACE. AS A RESULT, THE BALLOON WAS EXPLANTED AND REPLACED WITH A HIGHER-PRESSURE BALLOON. NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 24442442 ↗InjuryFeb 20, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH RECURRING INCONTINENCE AND URETHRAL ATROPHY. THE AUS WAS EXPLANTED AND REPLACED, AND THE CUFF WAS DOWNSIZED BECAUSE IT HAD BEEN INTENTIONALLY SIZED UP DURING THE PREVIOUS PROCEDURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.
Patient problems: Unspecified Tissue Injury; Urinary Incontinence
MAUDE report 24402883 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE. THE PHYSICIAN STATED THAT TROUBLESHOOTING DURING THE APPOINTMENT WAS UNSUCCESSFUL; THEREFORE, A DECISION WAS MADE TO REVISE THE CUFF. THE PATIENT WAS SCOPED PRIOR TO THE PROCEDURE. DURING THE REVISION SURGERY, THE ORIGINAL CUFF WAS REMOVED AND REPLACED WITH A NEW CUFF. THE PHYSICIAN SUSPECTED THAT THE RECURRENT INCONTINENCE WAS RELATED TO ATROPHY AT THE CUFF SITE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.
Patient problems: Unspecified Tissue Injury; Urinary Incontinence
MAUDE report 24080729 ↗InjuryJan 7, 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 CUFF WAS EXPLANTED AND REPLACED WITH A SMALLER ONE TO ENSURE BETTER SURGICAL OUTCOME FOR SPHINCTER FUNCTION. NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 23995157 ↗InjuryDec 26, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE. THE PHYSICIAN BELIEVES THAT THE CUFF BEING TOO BIG COULD HAVE CAUSED OR CONTRIBUTED TO THE INCONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE AUS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 23897451 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. URETHRAL ATROPHY IS THE SUSPECTED CAUSE OF THE INCONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE CUFF. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Tissue Injury; Urinary Incontinence
MAUDE report 23865605 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) IMPLANT DEVICE WAS EXPERIENCING RECURRING BREAKTHROUGH INCONTINENCE AND THE URETHRA HAD ATROPHIED. THE PHYSICIAN REMOVED THE DEVICE THROUGH EXTRACTION SURGERY, AND THERE WERE NO FURTHER SIGNS OR SYMPTOMS REPORTED.
Patient problems: Unspecified Tissue Injury; Urinary Incontinence
MAUDE report 23863086 ↗InjuryDec 19, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT URINARY INCONTINENCE AND INDICATED THAT THE CUFF WAS NOT FUNCTIONING PROPERLY. IMAGING CONFIRMED THAT THE BALLOON WAS INTACT AND FUNCTIONING AS EXPECTED. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE EXISTING 5.5 CM CUFF WITH A 4.5 CM CUFF. CYSTOSCOPY DEMONSTRATED APPROPRIATE URETHRAL COAPTATION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 23849464 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED CUFF EROSION AND INCONTINENCE. AFTER THE URETHRA HEALED, A SURGICAL PROCEDURE WAS PERFORMED IN WHICH A NEW AUS WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Erosion; Urinary Incontinence
MAUDE report 23705285 ↗InjuryDec 3, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS EXPERIENCING RECURRING INCONTINENCE. CLINICAL EVALUATION SHOWED THAT THE DEVICE WAS CYCLING APPROPRIATELY, AND IT WAS DETERMINED THAT A SMALLER CUFF WAS NEEDED TO IMPROVE CONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING CUFF WAS REMOVED AND REPLACED WITH A SMALLER ONE, WHILE THE PRESSURE-REGULATING BALLOON AND CONTROL PUMP WERE RETAINED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 23703959 ↗InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCE RECURRING INCONTINENCE. FOLLOWING UROLOGIST CONSULTATION, A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE CUFF, AS ATROPHY WAS SUSPECTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Tissue Injury; Urinary Incontinence
MAUDE report 23666142 ↗
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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