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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
Brand
Inari Medical Oak Canyon
Lot Codes / Batch Numbers
UDI-DI:00850291007277. All lots. IU-01011 REV. C.
Products Sold
UDI-DI:00850291007277. All lots. IU-01011 REV. C.
Inari Medical Oak Canyon is recalling ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Cathete due to Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, ca. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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: - Avoid pulling the ClotTriever XL Catheter caudal to cranial through upper extremity or jugular vein access. - To prevent advancing clot from veins into heart/pulmonary arteries, ensure that the ClotTriever XL Catheter is slowly retracted distally away from the heart, while maintaining sheath position and visualization under fluoroscopy. -Operation of a thrombectomy catheter may cause embolization of some thrombus and/orthrombotic particulate, physician discretion advised. The potential for extensive and/or difficult to treat pulmonary thromboembolism should be carefully considered when ClotTriever XLCatheter is used to engage and remove thrombus from large vessels such as the inferior venacava (IVC). 2. Prior to Use: -To minimize risk of embolization of blood clots, use of a device that entraps clots is recommended. 3. Procedure: - In the presence of excessive clot volume, it is recommended to sequentially remove portions of thrombus. Avoid removal of the entire clot in one pass. 4. Contraindications The existing IFU states: "Not indicated for the removal of predominantly fibrous, firmly adherent, or calcified material." "Review of patient history and pre-procedure imaging may aid in identifying patients with these lesion types. - Contraindicated in patients with suspected tumor thrombus.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026