Deactivation Package 72400095Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878953000664), received between Dec 5, 2019 and Dec 3, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) REVISION SURGERY BECAUSE HE WAS UNABLE TO PUMP DUE TO FLUID LOSS. THE LOCATION AND SOURCE OF THE FLUID LOSS WAS THE BALLOON. UPON EXPLANT, A HOLE IN THE TUBING WAS IDENTIFIED, IT IS SUSPECTED THAT THE PHYSICIAN MAY HAVE ACCIDENTALLY CUT IT. THE HOLE WAS IDENTIFIED BECAUSE SALINE WAS INSERTED INTO THE BALLOON, AND IT DID NOT HOLD THE FLUID. THERE WAS NOT MUCH FLUID LEFT IN THE DEVICE. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20829011 ↗
• InjuryDec 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DEACTIVATION OF AN ARTIFICIAL URINARY SPHINCTER (AUS) DEVICE DUE TO UNSPECIFIED REASONS. A PATIENT OUTCOME WAS NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9414890 ↗