BIB® 614445Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964900228), received between Feb 15, 2021 and Feb 15, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 other recall cover devices cleared under the same FDA submission (K050857, K160889); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  BIB USED IN MELODY VALVE CASE. COVERED MOUNTED CP STENT (CMCP033) DEPLOYED. 2 PAL MAZ DEPLOYED WITHIN THE CP. USED BIB# 614445 TO FLARE THE EDGE OF THE STENT. BIB RUPTURED CIRCUMFERENTIALLY INSIDE PATIENT. REQUIRED CARDIAC SURGICAL CUT DOWN TO GET EVERYTHING OUT SAFELY AND THEN FINISHED VALVE IMPLANT. THE INNER BALLOON WAS INFLATED BEFORE THE OUTER BALLOON. THE CATHETER SHAFT WAS NOT KINKED. A PRESTO INFLATION DEVICE WAS USED. THE INTRODUCER SHEATH WAS A 22 FR DRY SEAL. PATIENT HAS A TRUNCUS TYPE 2 CARDIAC ANATOMY. POST PROCEDURE PATIENT CONDITION: PATIENT FULLY RECOVERED WITH INCISION THAT WAS NOT NECESSARY. ADDITIONAL INFORMATION RECEIVED ON 1/26/2021 - THE BIB THAT RUPTURED WAS USED TO DEPLOY THE SECOND OF THE PAL MAZ STENTS AND IT WAS USED TO FLARE THE PROXIMAL END OF THE STENT IMMEDIATELY AFTER DEPLOYMENT. ALSO THE BALLOON MARKERS ON THE BIB THAT RUPTURED WERE OFF - ACCOUNT MOUNTED THE STENT AT THE LOCATIONS OF THE BALLOON MARKERS HOOVER UPON INFLATION OF THE BALLOON IT WAS CLEAR THAT THE STENT WAS NOT CENTERED ON THE BALLOON. ACCOUNT IMPLANTED THE COVERED CP STENT INITIALLY FOLLOWED BY 2 SEPARATE PAL MAZ STENTS TO FURTHER REINFORCE THE RADIAL STRENGTH OF THE STENTED OUTFLOW T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327328 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050857, K160889. One submission often covers many models, so check the product and lot details in each record.

• Z-1754-2025 · Apr 21, 2025 · Terminated
  BIB Balloon in Balloon Dilatation Catheter. Model Number: 420