Penumbra System Separator Flex 026 032 041 054 Models PSF026 PSF032 PSF041 PSF054

FDA-Cleared Indications

• Used with compatible Penumbra System components for the removal of thrombus from the peripheral vascular system.
• Intended for endovascular treatment of thrombotic or embolic occlusion when mechanical thrombectomy is clinically appropriate.
• The device is a catheter-based thrombus-retrieval component classified under FDA product code NRY.

Clinical Applications

• Mechanical thrombectomy for selected lower-extremity deep vein thrombosis.
• Endovascular removal of thrombus from selected pulmonary embolism cases when used with a compatible cleared Penumbra system.
• Thrombectomy of an occluded dialysis arteriovenous fistula or graft.
• Removal of thrombus from other appropriately sized peripheral vessels within the device labeling and compatible system instructions.

Reported off-label uses

• Use in selected arterial thrombectomy procedures outside the device's specific peripheral venous labeling may be reported in clinical practice, but this should not be assumed to be FDA-cleared for the device.
• Use in cerebral or intracranial thrombectomy should not be inferred from the general thrombus-retrieval product code; the specific device labeling and compatible system indications must be verified.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• Models are identified as PSF026, PSF032, PSF041, and PSF054; the correct size depends on the compatible Penumbra system, catheter configuration, access route, vessel or graft size, and thrombus location.
• The Separator Flex is generally used through an appropriately sized aspiration catheter under fluoroscopic or other endovascular imaging guidance by trained clinicians.
• Review the current device labeling and instructions for use for compatibility, maximum insertion depth, handling, and contraindications before use.
• MRI safety depends on the complete device system, whether the device remains in the patient, and the manufacturer's current labeling; do not assume that an implanted or retained component is MRI safe.
• Potential complications include bleeding, vascular injury or perforation, distal embolization, infection, contrast reaction, thrombosis, and complications related to sedation or vascular access.