Reported Aug 28, 2024 · Ongoing
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever…
Inari Medical - Oak Canyon
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inari Medical - Oak Canyon · 6001 Oak Cyn · Irvine, CA · 92618-5200
Is this the product you have?
- ClotTriever XL Catheter, 30 mm
- REF41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System
- ReferenceIU-01011
- Lot codes and dates
- UDI-DI00850291007277. All lots. IU-01011 REV. C
- Amount recalled
- 2488
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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