ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
Recall
- Recall Number
- Z-2587-2024
- Event Number
- 95069
- Firm
- Inari Medical Oak Canyon
- FEI Number
- 3020347218
- Product Code
- QEW
- Status
- Open, Classified
- Root Cause
- Labeling design
- Initiated
- July 19, 2024
- Posted
- August 21, 2024
- Address
- 6001 Oak Cyn, Irvine, CA, 92618-5200
Description
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
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.
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.
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.
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