BIB® 614444Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964900211), received between Jul 24, 2018 and Jul 24, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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.

• MalfunctionJul 24, 2018Material Rupture

  THE PRODUCT PERFORMED WELL AND DID ITS JOB, BUT AFTER INFLATING FOR THE LAST TIME IT RUPTURED. THE BALLOON RUPTURED LONGITUDINALLY AT 3 ATM. THE INDICATION THE PHYSICIAN WAS USING THE BALLOON FOR: MAIN PULMONARY ARTERY VALVULOPLASTY. AN INFLATION DEVICE WITH PRESSURE GAUGE USED. A 12 F COOK INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE PATIENT WAS OK POST PROCEDURE. A SECOND BALLOON WAS NOT NEEDED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7713510 ↗

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