AMS 800 Artificial Urinary Sphincter 72404130Recalls & 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 implanted cuff and pump that helps control urination in people with urinary incontinence. Of its 1,783 reports, 1 involves a death and 1,756 involve an injury, and many describe fluid leaking from the system, mechanical problems, and incontinence returning, sometimes requiring the device to be replaced. Some also mention erosion and tissue injury. 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
- 1,803
- Deaths reported
- 1
- Injuries reported
- 1,776
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,803 adverse event reports that list this exact device (DI 00878953003085), received between Oct 3, 2018 and Sep 29, 2026 — classified as 1 death, 1,776 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (354 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 Problem681
- Mechanical Problem354
- Fluid/Blood Leak325
- Insufficient Device Problem Information305
- Inadequacy of Device Shape and/or Size177
- Material Puncture/Hole143
- Defective Device51
- Malposition of Device39
Patient problems
- Urinary Incontinence953
- Unspecified Tissue Injury290
- Erosion284
- Incontinence196
- No Clinical Signs, Symptoms or Conditions171
- Urinary Retention84
- Tissue Damage79
- Unspecified Infection58
Recent adverse event reports
The 25 most recent of 1,803 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Insufficient Device Problem Information
It was reported that this patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence after a recent surgery was performed to replace Pressure Regulating Balloon (PRB) with higher pressure. A surgical procedure was now performed during which the PRB and cuff were explanted and replaced with a smaller size cuff and lower pressure PRB. No additional information was provided.
Patient problems: Urinary Incontinence
MAUDE report 50937969 ↗InjurySep 29, 2026Insufficient Device Problem Information
It was reported that this patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. 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 50937759 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced erosion of the balloon tube. A surgical procedure was performed during which the existing balloon and pump were explanted the cuff remains in place. There were no further patient complications reported.
Patient problems: Erosion; Unspecified Infection
MAUDE report 50932394 ↗InjurySep 29, 2026Mechanical Problem; Malposition of Device
It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. Upon revision, it was noted that the balloon was malposition and the system did not cycle correctly. A surgical procedure was performed during which the existing device was explanted and replaced. There were no further patient complications reported.
Patient problems: Urinary Incontinence
MAUDE report 50932270 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this Artificial Urinary Sphincter (AUS)'s cuff eroded. As a result, the device was explanted. No further patient complications were reported.
Patient problems: Erosion
MAUDE report 50916422 ↗InjurySep 28, 2026Mechanical Problem
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50916368 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this patient with an Artificial Urinary Sphincter (AUS) experienced recurring incontinence. A surgical procedure was performed during which the cuff was explanted and replaced with a smaller size. There were no device issues, and no additional information was provided.
Patient problems: Urinary Incontinence
MAUDE report 50897597 ↗InjurySep 23, 2026Fluid/Blood Leak; Mechanical Problem
It was reported that this Artificial Urinary Sphincter (AUS) was not working. Upon inspection, fluid loss was noticed. As a result, the device was explanted and replaced. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873772 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring incontinence. A surgical procedure was performed to remove and replace all the components. No device issues and no further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50870138 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence due to sub-cuff atrophy. A surgical procedure was performed during which the device was removed and replaced. The outcome after the revision procedure was not available at the time of the report.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50867427 ↗InjurySep 18, 2026Fluid/Blood Leak
Patient problems: Urinary Incontinence
MAUDE report 50823277 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Urinary Incontinence
MAUDE report 50819545 ↗InjurySep 16, 2026Migration
Patient problems: Urinary Incontinence
MAUDE report 50793069 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence, urethral erosion and urethral cuff atrophy. As a result, the device was explanted and replaced. The cuff was downsized. No further patient complications were reported.
Patient problems: Erosion; Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50791074 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient with an Artificial Urinary Sphincter (AUS) developed a urethral stricture. It is unknown whether the stricture is related to the placement of the cuff. A surgical procedure was performed to remove the cuff. The tubing to the pump was plugged. Urethroplasty was performed to address the stricture. No further patient complications were reported.
Patient problems: Urethral Stenosis/Stricture
MAUDE report 50789858 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence. As a result, the device was explanted and replaced. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50788568 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence. The patient went to a double cuff to a single cuff. As a result, a new cuff was added. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50787716 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient with an Artificial Urinary Sphincter (AUS) presented recurring incontinence due to urethral atrophy. A surgical procedure was performed during which the existing device was explanted and replaced with a new AUS. Also, the cuff was downsized from a 4.0 to a 3.5 . There were no further patient complications reported.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50777604 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Artificial Urinary Sphincter (AUS) experienced recurring urinary incontinence. Cuff site atrophy was identified as a contributing factor. A surgical procedure was performed in which the existing device was explanted and replaced. There were no further patient complications reported.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50766221 ↗InjurySep 15, 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 atrophy. As a result, the cuff was explanted and replaced. No further patient complications were reported.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50766217 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50763305 ↗InjurySep 14, 2026Insufficient Device Problem Information
It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence and cuff atrophy. A surgical procedure was performed to remove and replace the AUS. No further patient complications were reported.
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50757891 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50724738 ↗InjurySep 10, 2026Fluid/Blood Leak; Detachment of Device or Device Component
Patient problems: Urinary Incontinence
MAUDE report 50718181 ↗InjurySep 10, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole
It was reported that a patient with an Artificial Urinary Sphincter (AUS) requested explantation of the device because was not functioning. A surgical procedure was performed to remove the and replace the AUS. It was determined that the device exhibited fluid loss due to a hole in the cuff, and both the balloon and cuff exhibited inflation issues. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717862 ↗
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-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 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
- 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.
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