FDAFDA · Food and drugs·Recall number Z-2587-2024
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
Published August 28, 2024 · Recall initiated: July 19, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Inari Medical - Oak Canyon
- Distributor
- 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.
- Lot
- UDI-DI:00850291007277. All lots. IU-01011 REV. C.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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