AMS 800 Artificial Urinary SphincterRecalls & reported problems across all models
Boston Scientific Corporation · 31 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one AMS 800 Artificial Urinary Sphincter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7,515
- Deaths reported
- 2
- Injuries reported
- 7,276
- Recalls
- 2
We found 31 models of AMS 800 Artificial Urinary Sphincter by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 7,515 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2018 and Sep 30, 2026 — classified as 2 deaths, 7,276 injuries, 237 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (1,800 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
AMS 800 Artificial Urinary Sphincter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 28, 2024Open, Classified
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Z-0531-2025 · Root cause: Error in labeling · Recall details · FDA record ↗
- Oct 28, 2024Open, Classified
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Z-0530-2025 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported AMS 800 Artificial Urinary Sphincter problems
Device problems
- Adverse Event Without Identified Device or Use Problem2,182
- Mechanical Problem1,800
- Fluid/Blood Leak1,672
- Insufficient Device Problem Information1,077
- Material Puncture/Hole1,046
- Inadequacy of Device Shape and/or Size740
- Migration300
- Defective Device256
Patient problems
- Urinary Incontinence3,543
- No Clinical Signs, Symptoms or Conditions1,228
- Unspecified Tissue Injury905
- Erosion872
- Incontinence859
- No Known Impact Or Consequence To Patient388
- Unspecified Infection300
- Tissue Damage233
AMS 800 Artificial Urinary Sphincter models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMS 800 Artificial Urinary Sphincter 72404130Device, Incontinence, Mechanical/Hydraulic1 death1,803 reports
- AMS 800 Artificial Urinary Sphincter 72404131Device, Incontinence, Mechanical/Hydraulic1,394 reports
- AMS 800 Artificial Urinary Sphincter 72400024Device, Incontinence, Mechanical/Hydraulic1 recall1 death999 reports
- AMS 800 Artificial Urinary Sphincter 720157-01Device, Incontinence, Mechanical/Hydraulic591 reports
- AMS 800 Artificial Urinary Sphincter 72404132Device, Incontinence, Mechanical/Hydraulic576 reports
- AMS 800 Artificial Urinary Sphincter 72400160Device, Incontinence, Mechanical/Hydraulic487 reports
- AMS 800 Artificial Urinary Sphincter 72404127Device, Incontinence, Mechanical/Hydraulic443 reports
- AMS 800 Artificial Urinary Sphincter 72400161Device, Incontinence, Mechanical/Hydraulic358 reports
- AMS 800 Artificial Urinary Sphincter 72404133Device, Incontinence, Mechanical/Hydraulic220 reports
- AMS 800 Artificial Urinary Sphincter 72400098Device, Incontinence, Mechanical/Hydraulic1 recall137 reports
- AMS 800 Artificial Urinary Sphincter 72400162Device, Incontinence, Mechanical/Hydraulic111 reports
- AMS 800 Artificial Urinary Sphincter 720133-01Device, Incontinence, Mechanical/Hydraulic99 reports
- AMS 800 Artificial Urinary Sphincter 72404134Device, Incontinence, Mechanical/Hydraulic82 reports
- AMS 800 Artificial Urinary Sphincter 72400163Device, Incontinence, Mechanical/Hydraulic58 reports
- AMS 800 Artificial Urinary Sphincter 72400025Device, Incontinence, Mechanical/Hydraulic27 reports
- AMS 800 Artificial Urinary Sphincter 72400023Device, Incontinence, Mechanical/Hydraulic26 reports
- AMS 800 Artificial Urinary Sphincter 72400164Device, Incontinence, Mechanical/Hydraulic20 reports
- AMS 800 Artificial Urinary Sphincter 72400165Device, Incontinence, Mechanical/Hydraulic13 reports
- AMS 800 Artificial Urinary Sphincter 72404135Device, Incontinence, Mechanical/Hydraulic13 reports
- AMS 800 Artificial Urinary Sphincter 72400166Device, Incontinence, Mechanical/Hydraulic11 reports
- AMS 800 Artificial Urinary Sphincter 72400168Device, Incontinence, Mechanical/Hydraulic11 reports
- AMS 800 Artificial Urinary Sphincter 72400167Device, Incontinence, Mechanical/Hydraulic8 reports
- AMS 800 Artificial Urinary Sphincter 720066-01Device, Incontinence, Mechanical/Hydraulic6 reports
- AMS 800 Artificial Urinary Sphincter 72404137Device, Incontinence, Mechanical/Hydraulic4 reports
- AMS 800 Artificial Urinary Sphincter 72404138Device, Incontinence, Mechanical/Hydraulic4 reports
- AMS 800 Artificial Urinary Sphincter 72404140Device, Incontinence, Mechanical/Hydraulic4 reports
- AMS 800 Artificial Urinary Sphincter 72400170Device, Incontinence, Mechanical/Hydraulic3 reports
- AMS 800 Artificial Urinary Sphincter 72404136Device, Incontinence, Mechanical/Hydraulic2 reports
- AMS 800 Artificial Urinary Sphincter 72404142Device, Incontinence, Mechanical/Hydraulic2 reports
- AMS 800 Artificial Urinary Sphincter 72404144Device, Incontinence, Mechanical/Hydraulic2 reports
- AMS 800 Artificial Urinary Sphincter 72400172Device, Incontinence, Mechanical/Hydraulic1 report
Recent AMS 800 Artificial Urinary Sphincter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak; Material Puncture/Hole; Human-Device Interface Problem
Patient problems: Urinary Incontinence
MAUDE report 50954927 ↗InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Urinary Incontinence
MAUDE report 50953784 ↗InjurySep 30, 2026Inadequacy of Device Shape and/or Size
Patient problems: Urinary Incontinence
MAUDE report 50953249 ↗InjurySep 30, 2026Mechanical Problem; Material Puncture/Hole
Patient problems: Urinary Incontinence
MAUDE report 50952854 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50951306 ↗InjurySep 30, 2026Inadequacy of Device Shape and/or Size
Patient problems: Urinary Incontinence
MAUDE report 50948243 ↗InjurySep 30, 2026Material Puncture/Hole
It was reported that this Artificial Urinary Sphincter (AUS) was not functioning properly. Upon inspection, a crack was found in the pump connecting tube. A surgical procedure was performed during which the existing device was explanted and replaced with a new AUS. There were no patient complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947547 ↗InjurySep 29, 2026Difficult or Delayed Activation; Migration; Air/Gas in Device
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50940074 ↗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, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50937843 ↗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, 2026Material Puncture/Hole
It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. A surgical procedure was performed, during which a hole in the cuff was found. As a result, the cuff was removed and replaced. The hole was discovered when the physician took a string and fill the cuff. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50933396 ↗InjurySep 29, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole
It was reported that a patient with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. The patient stated that the device stopped functioning. A surgical procedure was performed, during which a small hole was found at the neck of the balloon, which caused a fluid loss. As a result, the AUS was removed. No further patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933268 ↗InjurySep 29, 2026Material Puncture/Hole
Patient problems: Urinary Incontinence
MAUDE report 50933064 ↗InjurySep 29, 2026Fluid/Blood Leak; Material Puncture/Hole
It was reported that the patient was experiencing incontinence with the Artificial Urinary Sphincter (AUS). Upon inspection, fluid loss and a hole in the balloon was noticed. As a result, the device was explanted and replaced with a higher-pressure balloon. No further patient complications were reported.
Patient problems: Urinary Incontinence
MAUDE report 50932836 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 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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