Cook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk
Cook Inc. is recalling Beacon Tip catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
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 is classified as FDA Class II and involves a structural defect (tip fracture/separation) that can lead to significant injury, such as embolization or occlusion of blood flow, meeting the criteria for a Severe rating.
Plain-English summary
Cook Inc. is recalling 332,255 units of Beacon Tip Centimeter Sizing Catheters, Beacon Tip White Vessel Sizing Catheters, and Beacon Tip Vessel Sizing Catheters. These intravascular diagnostic catheters are intended for use in angiographic procedures by trained physicians. The recall covers all lots of the affected catalog prefixes NR5.0.
The recall is being issued due to an increase in reports of polymer degradation of the catheter tip, which can result in tip fracture and/or separation. This degradation can lead to loss of device function or the separation of a device segment, requiring medical intervention. Complications from separated segments 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.
The affected products were distributed worldwide, including nationwide in the United States and to numerous international locations. Consumers and healthcare providers should stop using these specific catheters and contact Cook Inc. for further instructions on the recall.
The recalled product
- Product
- Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheter
- Affected units
- 332,255
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots. Catalog prefixes NR5.0 Catalog/product number
Distribution
Part of a larger recall action
This product is one of 14 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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