Cook Incorporated is recalling 15,769 Centimeter Sizing Catheters because the marker bands on the devices may crack or break during medical procedures. These catheters are used in angiographic procedures to measure anatomy, but if the bands fail, fragments can separate inside a patient's body. This defect can lead to increased surgery time, vessel injury, or life-threatening complications. Consumers should verify if their healthcare facility possesses any of the hundreds of affected lot numbers spanning the Centimeter Sizing, Aurous, and Beacon Tip models.
The marker bands can crack or break off, causing device fragments to enter the patient's bloodstream. This can cause internal vessel injury or blockages which, in the worst-case scenario, may be life-threatening or fatal.
Angiographic catheter available in various French sizes and materials.
Single-use, sterile catheter with gold marker bands.
Available in lengths of 70 and 100 cm and various tip configurations (straight, PIG, and VCF).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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