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BIB® 614446Recalls & reported problems

B Braun Interventional Systems, Inc · BB064 BIB Catheter 22 4.5 11F · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964900235), received between Aug 26, 2022 and Aug 26, 2022 — 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

Device problems

  • Material Rupture1
  • Off-Label Use1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 26, 2022Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

    BALLOON RUPTURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15300016 ↗

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

Other Catheter, angioplasty, peripheral, transluminal, dual-balloon devices

All Catheter, angioplasty, peripheral, transluminal, dual-balloon devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.