AMS 800 Artificial Urinary Sphincter 72400170Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878953000800), received between Oct 28, 2019 and Sep 19, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCE RECURRING INCONTINENCE DUE TO THE DEVICE NOT WORKING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED TO EXPLANT THE DEVICE AND REPLACED WITH A NEW AUS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23101172 ↗
• InjuryJun 30, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REMOVAL OF AN ARTIFICIAL URINARY SPHINCTER(AUS) DEVICE DUE TO A HOLE IN THE CUFF AND THE DEVICE NOT FUNCTIONING. A PATIENT OUTCOME WAS NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10211910 ↗
• InjuryOct 28, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DUE TO EROSION OF THE CUFF THROUGH THE VAGINAL WALL AND A PIN POINT LEAK IN THE CUFF, THE PATIENT HAD HIS ARTIFICIAL URINARY SPHINCTER (AUS) 9.0 CM CUFF REMOVED. THE SURGEON LEFT THE BALLOON AND PUMP STILL IMPLANTED INSIDE THE PATIENT. THE SURGEON REPAIRED THE TISSUE AT THE EROSION LOCATION. THE PHYSICIAN STATED THAT IN 2 MONTHS THE PATIENT WILL BE RE-IMPLANTED WITH A NEW CUFF. IT WAS FURTHER REPORTED THAT THE BECAUSE OF THE EROSION WAS DUE TO THE PATIENT'S PREVIOUS SURGERIES AND CANCER TREATMENT, AND THE PHYSICIAN BELIEVES THE EROSION OCCURRED DUE TO VERY THIN VAGINAL WALL TISSUE UNDER PRESSURE BY THE BLADDER NECK." THE ONSET OF THE EROSION IS UNKNOWN AND THERE WERE PATIENT SYMPTOMS RELATED TO THE FLUID LEAK IN CUFF. THE PATIENT IS STABLE AFTER THIS SURGERY BUT IT WITHOUT ANY CUFF CONNECTED TO THE IMPLANTED SYSTEM DUE TO THE REMOVAL OF THE CUFF. THE PHYSICIAN REPAIRED THE ERODED TISSUE AND WILL BE GIVEN SEVERAL MONTHS TO HEAL BEFORE IMPLANTING A NEW CUFF.

  Patient problems: Erosion

  MAUDE report 9245639 ↗

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, Classified
  AMS Artificial Urinary Sphincter Control Pump
• Z-0531-2025 · Oct 28, 2024 · Open, Classified
  AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
• Z-2442-2019 · Jul 19, 2019 · Terminated
  AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
• Z-1280-2013 · Mar 1, 2013 · Terminated
  AMS 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 · Terminated
  AMS 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 · Terminated
  AMS 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