Agency classClass IIOur severity:Severe FDA (Devices)·Z-2614-2016·Announced 2016-08-31

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category: Medical Device — Intravascular Catheter
Hazard: device-fracture
embolization
vascular-occlusion
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

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

See all 14 products in this recall →

Same manufacturer · Cook Inc.

See all →

High
Skinny Needle with Chiba Tip recalled for debris contamination
FDA (Devices) · 2021-12-29
High
Cook Flexor Check-Flo Introducer recalled for size mislabeling
FDA (Devices) · 2021-12-22
Moderate
Flexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
FDA (Devices) · 2021-12-22
High
Transseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
High
Transseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24

Same hazard · device fracture