FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA

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.