FDA Device Recall Z-2587-2024
Inari Medical - Oak Canyon · Irvine, CA
Class I — life-threatening Ongoing
Device
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
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.
Recall record
- Recall number
Z-2587-2024- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- 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.
- Recall initiated
- 2024-07-19
- Classified by FDA Center
- 2024-08-21
- FDA published
- 2024-08-28
- Recalling firm
- Inari Medical - Oak Canyon
- Firm location
- Irvine, CA
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.