FDAApril 21, 2025device
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
numed
UPCs
04046964899768
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMulti-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.2018-10-17
- FDAMulti-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.2018-10-17
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