Inari Medical - Oak Canyon
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Inari Medical - Oak Canyon and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-05-14FDA-DeviceClass IIArtix MT Thrombectomy Device, REF: 32-102
Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.
- 2024-08-28FDA-DeviceClass IClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
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.
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