Z-2587-2024Class I

ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter...

Name: Z-2587-2024 ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter...
Creator: Inari Medical - Oak Canyon
Published: 2024-07-19
License: https://open.fda.gov/license/

Inari Medical, Inc. / initiated 2024-07-19 / Open, Classified / root cause: labeling and UDI

FDA source

Inari Medical - Oak Canyon began a recall of ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011 on 2024-07-19. FDA classified it as Class I and gives the reason as "Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2587-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-07-19
Posted: 2024-08-21
Recalling firm: Inari Medical, Inc.
Product: ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
Product code: QEW Peripheral Mechanical Thrombectomy With Aspiration
Reason for recall: Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 7/19/24, correction notices were mailed to customers who were asked to do the following: 1) Review and disseminate to notice to any applicable personnel and device users at your facility and network and to any organization where affected devices were transferred. 2. We will update all catheter-related training content to align with the IFU updates. 3) Complete and return the acknowledgement form via email to [email protected] If you have any questions, contact firm's Customer Care at 877-923-4747, or email [email protected]. The following IFU sections are being updated: 1.Warnings: - Avoid pulling the ClotTriever XL Catheter caudal to cranial through upper extremity or jugular vein access. - To prevent advancing clot from veins into heart/pulmonary arteries, ensure that the ClotTriever XL Catheter is slowly retracted distally away from the heart, while maintaining sheath position and visualization under fluoroscopy. -Operation of a thrombectomy catheter may cause embolization of some thrombus and/orthrombotic particulate, physician discretion advised. The potential for extensive and/or difficult to treat pulmonary thromboembolism should be carefully considered when ClotTriever XLCatheter is used to engage and remove thrombus from large vessels such as the inferior venacava (IVC). 2. Prior to Use: -To minimize risk of embolization of blood clots, use of a device that entraps clots is recommended. 3. Procedure: - In the presence of excessive clot volume, it is recommended to sequentially remove portions of thrombus. Avoid removal of the entire clot in one pass. 4. Contraindications The existing IFU states: "Not indicated for the removal of predominantly fibrous, firmly adherent, or calcified material." "Review of patient history and pre-procedure imaging may aid in identifying patients with these lesion types. - Contraindicated in patients with suspected tumor thrombus.
Quantity in commerce: 2488
Distribution: Worldwide - US Nationwide distribution including in the states of PA, FL, GA, CA, IL, SC, NY, MN, UT, TN, WI, MI, KS, SD, AZ, AR, IN, KY, TX, AL, MS, DE, MA, OH, MO, WV, VA, NC, NV, CO, NE, OR, NM, NH, NJ, CT, ID, IA, WA, MD, OK, RI, DC, PR, LA, ND, VT and the countries of New Zealand, Chile, Australia.
Product codes and lots: UDI-DI:00850291007277. All lots. IU-01011 REV. C.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2587-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2587-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-21

Product code QEW

K223210Class IIClotTriever XL CatheterInari Medical, Inc. / cleared 2023-04-27

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)