BIB® 614396Recalls & reported problems
B Braun Interventional Systems, Inc · BB005 BIB Catheter 10 3 8F · Class 2
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Apr 21, 2025Terminated
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
Z-1754-2025 · Root cause: Mixed-up of materials/components · FDA record ↗
Other Catheter, angioplasty, peripheral, transluminal, dual-balloon devices
- BIB® 614446B Braun Interventional Systems, Inc · Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614440B Braun Interventional Systems, Inc · Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614444B Braun Interventional Systems, Inc · Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614451B Braun Interventional Systems, Inc · Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614445B Braun Interventional Systems, Inc · Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.