Recall Z-2587-2024 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
Inari Medical - Oak Canyon
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
| Date | Aug 21, 2024 (initiated Jul 19, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 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: - |
| Quantity | 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, Austra |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223210 | ClotTriever XL Catheter Inari Medical, Inc., Apr 27, 2023 |