FDA
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
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.
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 Quality@ostialflash.com.
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.