BIB® 614451Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964900280), received between Apr 23, 2019 and Apr 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.

• MalfunctionApr 23, 2019Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem; Inadequate User Interface

  ON (B)(6) 2019 NUMED RECEIVED A MEDWATCH REPORT FROM THE FDA THAT WAS SENT VIA USPS (MW5085855). THIS MEDWATCH REPORT WAS FROM THE USER FACILITY BUT LACKED USER FACILITY INFORMATION, CONTACT INFORMATION, AND AN ACCURATE LOT NUMBER FOR THE DEVICE. BASED ON THE STERILIZATION LOT NUMBER REFERENCED ON THE REPORT, NUMED WAS ABLE TO DETERMINE THE ACCURATE LOT NUMBER. NUMED CONTACTED THE DISTRIBUTOR IN THE U.S. FOR MORE INFORMATION ON THE DISTRIBUTION OF THE DEVICE AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: "ON (B)(6) 2019 FROM THE ACCOUNT VIA EMAIL: "I AM CONTACTING YOU BECAUSE OF AN ISSUE THAT WE HAD WITH A BIB BALLOON DURING A PROCEDURE THIS WEEK AND JUST WANTED TO TALK TO YOU AND DISCUSS IT TO SEE IF THERE IS SOMETHING WE CAN DO TO RESOLVE A POTENTIAL PROBLEM IN THE FUTURE." BIS MEDICAL DEVICE SPECIALIST (MDS) SPOKE TO THE ACCOUNT AND SENT THIS MESSAGE: "MORE OF AN INVENTORY QUESTION AND NOT A PIR." ON (B)(6) 2019 - PER A CONVERSATION WITH BIS MDS AND PETER FLOSDORF: THE TECH PULLED AN INCORRECT SIZE BECAUSE OF LACK OF TRAINING AT THE ACCOUNT. THE TECH USED THE INNER BALLOON SIZE INSTEAD OF THE OUTER BALLOON SIZE. THE ACCOUNT WILL CONDUCT INTERNAL TRAINING TO RECTIFY. THIS IS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8541022 ↗

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