Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Fracture
Cook Inc. is recalling Slip-Cath 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 involves a medical device defect (tip fracture/separation) that can lead to serious complications such as embolization to the heart or lungs or occlusion of blood flow to end organs, meeting the criteria for 'significant injury' or severe risk under the rubric.
Plain-English summary
Cook Inc. is recalling 298,340 units of Slip-Cath Beacon Tip Catheters, which are intravascular diagnostic catheters intended for use in angiographic procedures by trained physicians. The recall is due to an increase in reports of polymer degradation at the catheter tip, which can result in tip fracture or separation.
The degradation may lead to loss of device function or the separation of a device segment, requiring medical intervention. Complications from separated segments can include device fragments remaining 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 occlude blood flow to end organs.
The affected products were distributed worldwide, including in the United States and numerous international locations. The recall covers all lots with catalog prefixes SCBR5.0, SCBR5.5, and SCBR6.5. Users should stop using these devices and contact Cook Inc. for further instructions.
The recalled product
- Product
- Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
- Manufacturer
- Cook Inc.
- Affected units
- 298,340
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 (3)
- All Lots. Catalog prefixes SCBR5.0
- SCBR5.5
- and SCBR6.5 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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