Z-2299-2020Class II

Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI...

Name: Z-2299-2020 Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI...
Creator: Inari Medical
Published: 2020-03-23
License: https://open.fda.gov/license/

Inari Medical, Inc. / initiated 2020-03-23 / Terminated / root cause: manufacturing process

FDA source

INARI MEDICAL began a recall of Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079 on 2020-03-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2299-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-23
Posted: 2020-06-09
Terminated: 2021-08-13
Recalling firm: Inari Medical, Inc.
Product: Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
Product code: DXE Catheter, Embolectomy
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
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.
Quantity in commerce: 318
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.
Product codes and lots: Lot: 20010004, 20010005, 20010008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2299-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2299-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-08

Product code DXE

K182233Class IIFlowTriever Retrieval/Aspiration SystemInari Medical / cleared 2018-10-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)