Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
FDA Recall Z-2299-2020 · Posted None
Recalling FirmINARI MEDICAL
Recall StatusTerminated
Product CodeDXE
Date Initiated2020-03-23
Date Terminated2021-08-13
Product Quantity318
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.
Firm Action
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 [email protected]
Additional recall notices with an expanded scope, dated 03/26/20, were also sent to additional customers.
Root Cause
Equipment maintenance
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.