Cook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk
Cook Inc. is recalling specific femoral artery pressure monitoring catheter sets and trays because a manufacturing defect may cause the catheter tip to fracture or separate.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device defect that can lead to serious adverse events, including the need for medical intervention to retrieve a separated segment and complications from blood flow occlusion, which aligns with the 'Severe' criteria for significant injury reports or high-risk structural defects.
Plain-English summary
Cook Inc. is recalling 1,515 units of Femoral Artery Pressure Monitoring Catheter Sets and Trays. The affected products are single-lumen catheters, either uncoated or heparin-coated, used for venous or arterial pressure monitoring, blood sampling, and the administration of drugs and fluids. The recall covers specific catalog numbers and lots distributed worldwide, including the United States, Canada, Australia, Germany, China, Chile, the Dominican Republic, Panama, Israel, and Brazil.
The recall was initiated because a manufacturing process may lead to catheter tip fracture or separation. If the tip separates, it can result in the loss of device function, the need for medical intervention to retrieve the separated segment, or complications if the separated tip occludes blood flow to end organs.
Healthcare providers and facilities should identify any affected units by checking the catalog numbers and lot numbers listed in the official recall notice. Users should stop using the affected catheters and contact Cook Inc. for instructions on how to return or dispose of the products.
The recalled product
- Product
- Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheters
- Affected units
- 1,515
Distribution
Part of a larger recall action
This product is one of 4 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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