Inari Medical recalls ClotTriever XL Catheter (30mm, REF:41-102) due to risk of pulmonary embolism from improper use. All units are affected. Contact for remedy details.
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.
Inari Medical is recalling ClotTriever XL Cath: 30mm catheters with reference number 41-102. The recall is because these catheters can cause serious complications like pulmonary embolism if used incorrectly, especially when there's fibrous material or suspected tumors in the catheter bag or if the catheter is pulled through the vein without proper care.
The catheter can become blocked by fibrous, calcified material, or tumors, leading to device entrapment. If the catheter is pulled through the vein without proper care, it may cause pulmonary embolism, venous cutdown, or abdominal surgery.
Healthcare professionals using the ClotTriever XL Catheter for thrombectomy procedures are affected. Patients receiving this device are at risk if the catheter is used improperly.
Check for the ClotTriever XL Catheter (30mm) with reference number 41-102. All lots are affected. The device comes with Instructions for Use IU-01011 REV. C.
Check that you have the latest version of the Instructions for Use (IU-01011 REV. C) to ensure safe use.
Yes, all ClotTriever XL Catheters (30mm, REF:41-102) are affected. Check your device's reference number and instructions for use.
Review the latest Instructions for Use (IU-01011 REV. C) to ensure safe use. The recall does not require immediate removal but proper use is critical.
Yes, improper use can lead to pulmonary embolism, venous cutdown, or abdominal surgery if the catheter is blocked by fibrous material or pulled through the vein without care.
We’ve drafted a message you can send Inari Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2587-2024 — Inari Medical Inari Medical Hello, I own a Inari Medical that is covered by recall Z-2587-2024 from Inari Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
