AMS 800 Artificial Urinary Sphincter 72404134Recalls & 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 Boston Scientific AMS 800 artificial urinary sphincter is an implanted hydraulic incontinence device. Its reports mostly describe recurring urine leakage, often leading to revision surgery to downsize or replace the cuff, along with some tissue injury, erosion, fluid leaks or mechanical problems. There were 77 adverse event reports: 77 injuries and 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
- 82
- Deaths reported
- 0
- Injuries reported
- 82
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00878953003122), received between Mar 29, 2019 and Sep 24, 2026 — classified as 82 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (23 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 Problem39
- Inadequacy of Device Shape and/or Size23
- Insufficient Device Problem Information10
- Mechanical Problem9
- Fluid/Blood Leak5
- Material Puncture/Hole2
- Defective Device1
- Migration1
Patient problems
- Urinary Incontinence56
- Unspecified Tissue Injury15
- Incontinence11
- Erosion5
- Tissue Damage5
- Muscle Weakness/Atrophy4
- No Clinical Signs, Symptoms or Conditions4
- Urinary Retention3
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Inadequacy of Device Shape and/or Size
Patient problems: Urinary Incontinence
MAUDE report 50891866 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurrent incontinence and an inability to adequately coapt the urethra. During a revision surgery, the physician confirmed that the patient experienced incontinence due to atrophy. The cuff was explanted and replaced with a smaller cuff, and the remaining system components were retained. Additional information received stated that the cuff was appropriately sized and placed during the initial implant procedure. There were no further patient complications.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50857950 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Urinary Incontinence
MAUDE report 50764265 ↗InjurySep 10, 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 during which the existing 6.0 cuff was explanted and replaced with a new 5.0 cuff. There were no further patient complications reported.
Patient problems: Urinary Incontinence
MAUDE report 50714287 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence and cuff atrophy. As a result, the device was explanted and replaced. No further patient complications were reported.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50694853 ↗InjuryAug 18, 2026Insufficient Device Problem Information
It was reported that the patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. A revision procedure was performed during which the original 6.0 cm cuff was explanted and replaced with a 4.5 cm cuff. The original pressure regulating balloon (PRB) and pump were retained. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50311690 ↗InjuryAug 5, 2026Inadequacy of Device Shape and/or Size
It was reported that this patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence and the cuff was too big. A surgical procedure was performed during which the cuff was explanted and replaced with a smaller size cuff. No additional information was provided.
Patient problems: Urinary Incontinence
MAUDE report 50142273 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE. DURING REVISION SURGERY, THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE WITH A DOWNSIZED CUFF. THERE WERE NO FURTHER PATIENT COMPLICATIONS.
Patient problems: Urinary Incontinence
MAUDE report 25638526 ↗InjuryJun 18, 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 THE CUFF WAS REMOVED AND REPLACED WITH SMALLER SIZE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 25553606 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE. DURING A REVISION SURGERY, THE PHYSICIAN SUSPECTED URETHRAL ATROPHY; THEREFORE, THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 25325169 ↗InjuryMay 27, 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 DURING WHICH IT WAS IDENTIFIED THAT THE CUFF WAS TOO LARGE DUE TO URETHRAL ATROPHY. A 6.0 CM CUFF WAS REMOVED AND REPLACED WITH A 4.5 CM. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 25310980 ↗InjuryMay 6, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THIS PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE BUT WAS NEVER COMPLETELY DRY FOLLOWING THE INITIAL IMPLANT SURGERY IN (B)(6) 2025. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PHYSICIAN REMOVED THE 6.0 CUFF AND REPLACED WITH A 5.0 CUFF. THE PHYSICIAN SUSPECTED THE INITIAL CUFF WAS TOO LARGE SO DOWNSIZED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 25093991 ↗InjuryApr 22, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE. THE DEVICE WAS REPLACED TO IMPLANT A SMALLER CUFF. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 24958590 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) WAS NOT SATISFIED WITH THE LEVEL OF INCONTINENCE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE AUS. THE BALLOON WAS REPLACED FROM 51-60 TO 61-70 TO PROVIDE MORE PRESSURE TO THE CUFF. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 24592991 ↗InjuryMar 13, 2026Inadequacy of Device Shape and/or Size; Migration
IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT URINARY INCONTINENCE. DURING SURGICAL EVALUATION, THE BALLOON COMPONENT WAS FOUND TO HAVE HERNIATED OUT OF THE SPACE OF RETZIUS THROUGH THE ORIGINAL INCISION SITE IN THE LOWER ABDOMEN, WHERE IT HAD BEEN IMPLANTED. THIS DISPLACEMENT PREVENTED THE DEVICE FROM FUNCTIONING PROPERLY. THE BALLOON WAS REPLACED, AND FURTHER ASSESSMENT SHOWED THAT THE MIGRATION HAD ALSO PREVENTED THE CUFF FROM FULLY OCCLUDING THE URETHRA. CONSEQUENTLY, THE CUFF WAS REPLACED WITH A SMALLER SIZE, REDUCED FROM 6.0 CM TO 4.5 CM. IT WAS MENTIONED THAT THE PREVIOUS SURGEON DETERMINED THAT THE 6.0 CM CUFF PROVIDED A BETTER FIT FOR THE PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 24592255 ↗InjuryMar 9, 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, DURING WHICH THE CUFF WAS REMOVED AND REPLACED. NO DEVICE ISSUES OR OTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 24552612 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) IMPLANT DEVICE WAS EXPERIENCING RECURRING INCONTINENCE. THE PHYSICIAN BELIEVES THAT URETHRAL ATROPHY CAUSED THE CUFF TO BECOME TOO LOOSE AND NO LONGER COAPT THE URETHRA ADEQUATELY. THE PHYSICIAN REMOVED THE 6.0 CUFF AND REPLACED WITH A 4.5 CUFF THROUGH REPLACEMENT SURGERY, AND THERE WAS NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Unspecified Tissue Injury; Urinary Incontinence
MAUDE report 24424675 ↗InjuryFeb 4, 2026Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT URINARY INCONTINENCE. DURING A SURGICAL PROCEDURE, A HOLE AND LEAKAGE WERE IDENTIFIED IN THE CUFF. THE AUS WAS SUBSEQUENTLY EXPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 24258406 ↗InjuryJan 8, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING URINARY INCONTINENCE. DURING A SURGICAL PROCEDURE, URETHRAL ATROPHY WAS IDENTIFIED. THE CUFF WAS INTACT, AND NO DEVICE ISSUE WAS OBSERVED; HOWEVER, THE CUFF SIZE WAS TOO LARGE. THE 6.0 CM CUFF WAS REMOVED AND REPLACED WITH A 4.5 CM CUFF. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Tissue Injury; Urinary Incontinence
MAUDE report 24002503 ↗InjuryDec 17, 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) PRESENTED WITH SUB-CUFF EROSION OF THE URETHRA. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Erosion; Pain
MAUDE report 23835162 ↗InjuryDec 2, 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. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE ORIGINAL 6.0 CM CUFF WAS EXPLANTED. A NEW CUFF WAS REMEASURED, DOWNSIZED TO 5.0 CM, AND IMPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 23696934 ↗InjuryDec 1, 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) WAS EXPERIENCING RECURRING INCONTINENCE AND PER THE PATIENT WAS 80% DRY BUT THERE WAS STILL INCONTINENCE PRESENT. THERE WAS NO APPARENT DEVICE ISSUE AND NO FLUID LOSS. THE PREVIOUSLY PLACED CUFF WAS REPORTED TO BE TOO LARGE. THE PHYSICIAN REMOVED AND REPLACED THE CUFF DOWNSIZING TO A SMALLER ONE, AND THERE WERE NO FURTHER SIGNS OR SYMPTOMS REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 23686815 ↗InjuryNov 10, 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) PRESENTED RECURRING INCONTINENCE, IT WAS REPORTED THAT THE CUFF WAS TOO LARGE. THE AUS WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.
Patient problems: Urinary Incontinence
MAUDE report 23509073 ↗InjuryOct 15, 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 RECURRENT INCONTINENCE AND PAIN AFTER A URINARY TRACT INFECTION. A REVISION SURGERY WAS PERFORMED IN WHICH PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.
Patient problems: Pain; Urinary Incontinence; Urinary Tract Infection
MAUDE report 23286850 ↗InjurySep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT, VIA ULTRASOUND, FLUID LOSS WAS IDENTIFIED IN THIS ARTIFICIAL URINARY SPHINCTER (AUS), RESULTING IN THE DEVICE NOT WORKING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED; HOWEVER, THE SOURCE OF THE LEAKAGE COULD NOT BE DETERMINED. ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23000099 ↗
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 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