Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
White Lumax Guiding Coaxial Catheter Catheter Recalled by Cook Inc. Due to Increase in reports of polymer degradation of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cook Inc. directly.
Affected Products
White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
Quantity: 3,425
Why Was This Recalled?
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cook Inc.
Cook Inc. has 262 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report