Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FLASH Ostial System Recalled by Ostial Corporation Due to Angioplasty system has a manufacturing issue that has...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ostial Corporation directly.
Affected Products
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Quantity: 40
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ostial Corporation
Ostial Corporation has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report