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U.S. Department of Health and Human Services

Class 2 Device Recall Triever20

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 Class 2 Device Recall Triever20see related information
Date Initiated by FirmMarch 23, 2020
Create DateJune 09, 2020
Recall Status1 Terminated 3 on August 13, 2021
Recall NumberZ-2299-2020
Recall Event ID 85424
510(K)NumberK182233 
Product Classification Catheter, embolectomy - Product Code DXE
ProductTriever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
Code Information Lot: 20010004, 20010005, 20010008
Recalling Firm/
Manufacturer		 INARI MEDICAL
9 Parker Ste 100
Irvine CA 92618-1666
Manufacturer 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.
FDA Determined
Cause 2		Equipment maintenance
ActionOn 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.
Quantity in Commerce318
DistributionU.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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DXE
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