Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Fracture
Cook Inc. is recalling 60,302 Shuttle Select Slip-Cath catheters worldwide due to polymer degradation causing tip fracture and separation.
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.
Plain-English summary
Cook Inc. is recalling 60,302 units of the Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic. These catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. The recall covers all lots and is distributed worldwide, including the United States and numerous international locations.
The recall is being conducted due to an increase in reports of polymer degradation of the catheter tip, which results in tip fracture and/or separation. This degradation can lead to the loss of device function or the separation of a device segment, potentially 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.
Physicians and healthcare facilities should stop using the affected catheters and contact Cook Inc. for further instructions on the recall process.
The recalled product
- Product
- Shuttle Select Slip-Cath 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
- 60,302
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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