Recall Z-2309-2021 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Ostial Corporation
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
| Date | Jul 14, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 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 844-352-7 |
| Quantity | 40 |
| Distribution | US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122379 | FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM Ostial Corporation, Sep 5, 2012 |