ACCULIF 905103Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327067064), received between Mar 8, 2016 and May 23, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2017Device Expiration Issue

  IT WAS REPORTED THAT; WE ARE UNSURE BUT IT IS POSSIBLE THAT AN EXPIRED BOX OF TUBING WAS UTILIZED. THE SURGERY DATE WAS (B)(6) 2017 AND THE EXPIRATION DATE ON THE TUBING WAS 3/31/2017. THIS ITEM WAS NOT IN INVENTORY IN ORACLE TO RESERVE AS WE ONLY EVER RECEIVED 3 BOXES PER ORACLE AND THOSE 3 BOXES WERE PREVIOUSLY BILLED. WE ARE NOT SURE HOW/WHEN WE GOT THIS ITEM HOWEVER NOT IT WAS NOT TRANSACTED IN ORACLE TO US AND THEREFORE WAS NOT ON OUR EXPIRATION REPORT. SINCE THE ITEM WASN'T IN ORACLE TO TRANSACT AND SINCE THE SALES REPRESENTATIVE HAD 4 KITS, ONE OF WHICH BEING A LOANER, WE WAITED FOR THE KIT TO BE COUNTED UPON RETURN TO SEE IF ANOTHER LOT NUMBER WAS MISSING FROM THAT KIT (AND WOULD BE TRANSFERRED INTO OUR INVENTORY TO BILL) HOWEVER LOANERS DID NOT SHOW ANY OF THE ITEM MISSING FROM THEIR LOANER KIT. ADDITIONALLY, WE ASKED THE MAIN SALES REP AT THE ACCOUNT TO DO AN INVENTORY COUNT TO SEE WHAT LOT NUMBERS WERE IN THE OTHER KITS IN HIS POSSESSION TO SEE IF ANOTHER LOT NUMBER WAS MISSING AND MAY HAVE BEEN UTILIZED. SINCE THE STICKERS WERE NOT ON USAGE SHEET, ON (B)(6), WHEN WE ASKED THE SALES ASSOCIATE THAT COVERED THE SURGERY, HOW HE DETERMINED THE LOT NUMBERS STATED ON THE SURGE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6586502 ↗
• MalfunctionJun 15, 2016Fracture; Material Frayed; Activation Failure; Fracture

  IT WAS REPORTED THAT A TUBING SET FRAYED NEAR THE IMPLANT INTERFACE AND THE IMPLANT COULD NOT BE EXPANDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5726066 ↗
• MalfunctionMar 22, 2016Adverse Event Without Identified Device or Use Problem; Cut In Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TUBING ON THE INSERTER GOT CUT BY THE INSERTER WHILE INSERTING THE IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5516430 ↗
• MalfunctionMar 21, 2016Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem; Pressure Problem

  IT WAS REPORTED THAT; THE IMPLANT FAILED TO EXPAND IN SITU. SURGEON STATED THAT THERE WAS NO HYDRAULIC PRESSURE WHEN TURNING THE PLUNGER CLOCKWISE. WE THEN HAD THE SURGEON FILL UP THE PLUNGER WITH WATER AND ADDITIONAL TIME, IT WAS STILL REPORTED BY THE SURGEON THAT THERE WAS NO PRESSURE WHEN PLUNGER WAS TURNED CLOCKWISE WE PROCEEDED TO CHANGE OUT BOTH RED AND GREEN WASHER WITH REPLACEMENT RED AND GREEN WASHERS. THERE WAS STILL NO HYDRAULIC PRESSURE REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5514932 ↗
• MalfunctionMar 8, 2016Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem; Torn Material; Activation Failure

  IT WAS REPORTED THAT A TUBING HAD A GASH TORN IN IT, AND WOULDN'T EXPAND, USED IT AS A STATIC CAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5485787 ↗