FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
FDA Recall Z-2309-2021 · Posted None
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Recalling FirmOstial Corporation
Recall StatusTerminated
Product CodeLIT
Date Initiated2021-07-14
Date Terminated2024-01-30
Product Quantity40
Reason for Recall
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.
Firm Action
On 07/14/2021, recall notices were mailed to customers. Customers were asked to take the following actions:
1) Immediately examine your inventory and quarantine product subject to recall.
2) Return all unused inventory to the recalling firm. Please contact Customer Service at 844 352-7411.
3) Please complete the enclosed Customer Acknowledgement Form and submit to [email protected].
4) Please forward a copy of this notification to those within your organization that need to be aware.
Customers with additional questions or concerns are encouraged to contact Customer Service at 844-352-7411 Monday-Friday/8am-4pm PST or contact your local Field Representative.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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