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

FDA device recall Z-2587-2024 · posted 2024-08-21 · Open, Classified

Recall details

Recalling firm

Inari Medical - Oak Canyon

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.

Action taken

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 QA@inarimedical.com If you have any questions, contact firm's Customer Care at 877-923-4747, or email QA@inarimedical.com. 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.

Root cause

Labeling design

Status

Open, Classified

Product code

QEW

Quantity affected

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

Date initiated

2024-07-19

Date posted

2024-08-21

Location

Irvine, CA

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