Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
This recall has been terminated (originally issued March 23, 2020).
- Recall Initiated
- March 23, 2020
- Terminated
- August 13, 2021
- Recall Number
- Z-2299-2020
- Quantity
- 318
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected.
Distribution
U.S Distribution in the states of .: IA, GA, MO, MI, AZ, FL, NJ, MN, LA, PA, AL, OH, NY, WI, CA, TX, TN, NH, IL, NC, CT, CO, OK, OR, IN, MA, VA, KY, WA, MS, SC, UT, SD, ND, AR, ID, DE, including DC.
Lot / Code Info
Lot: 20010004, 20010005, 20010008
Root Cause
Equipment maintenance
Action Taken
On 03/23/20, Urgent Medical Device Recall notices were emailed to customers. Customers were asked to take the following actions: 1.Immediately review your inventory for the affected devices and quarantined to prevent their use. 2.Complete and return the Customer Response Form. 3.Return quarantined devices to recalling firm. 4.Report any adverse health consequences experienced with the use of this product to the recalling firm. Customers with additional questions were encouraged to contact the firm at: 877.923.4747 or customerservice@inarimedical.com Additional recall notices with an expanded scope, dated 03/26/20, were also sent to additional customers.