Z-2299-2020 Class II Terminated
FDA device recall Z-2299-2020 was initiated by INARI MEDICAL on March 23, 2020 and is designated Class II. 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 mu… The recall status is terminated (terminated August 13, 2021). Affected quantity: 318.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- March 23, 2020
- Termination Date
- August 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 318
Product Description
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
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 Pattern
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.
Code Information
Lot: 20010004, 20010005, 20010008