Sizing Catheter Recall: Cook Medical Removes Various Centimeter Sizing Catheters
Cook Medical has initiated a recall for various Centimeter Sizing Catheters due to an increased risk of marker bands cracking or breaking during angiographic procedures.
Cook Medical and healthcare facilities/clinicians utilizing these specific sizing catheters during angiography. Internal quality and regulatory departments at medical device firms manufacturing similar catheter components are also affected by the safety signal.
The mechanical failure of marker bands during a procedure poses significant patient safety risks, potentially leading to embolization or the need for additional surgical intervention. From a regulatory perspective, this suggests a potential material or manufacturing defect that may require a reassessment of component durability and performance standards for sizing markers.
Identify and quarantine affected inventory immediately. Regulatory teams should update risk management files to reflect higher probabilities of marker band failure, while QA should initiate a thorough CAPA to investigate the root cause of the material cracking/breakage.
When the sizing catheters are used during angiographic procedures the marker bands may be at an increased risk of cracking/breakage.
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