Reported Aug 25, 2021 · Terminated
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Ostial Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ostial Corporation · 197 E Hamilton Ave Ste 101 · Campbell, CA · 95008-0261
Is this the product you have?
- FLASH Ostial System, Dual Balloon Angioplasty Catheter
- REFOAB6014BA
- Lot codes and dates
- Lot82210399
- Amount recalled
- 40
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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