FDAJuly 14, 2021device
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.
What to do
FDA enforcement status: Terminated
Brands named
ostial
Recall history
No related federal recalls on record for this brand yet.
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