The Recall Desk
SevereFDA (Devices)·Z-2610-2016·Announced 2016-08-31

Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters Due to Tip Fracture

Cook Inc. is recalling Beacon Tip Torcon NB Advantage 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 risk of significant injury, including embolization to the heart or lungs and occlusion of blood flow to end organs, which aligns with the 'Severe' criteria for significant injury reports.

Plain-English summary

Cook Inc. is recalling the Beacon Tip Torcon NB Advantage Catheter, an intravascular diagnostic catheter. The recall is due to an increase in reports of polymer degradation at the catheter tip, which can result in tip fracture and/or separation.

The degradation may lead to a loss of device function or the separation of a device segment, which could require medical intervention. Complications from separated segments include fragments remaining in the vascular system, genitourinary system, or other soft tissues. If fragments enter the vascular system, they could result in embolization to the heart or lungs or occlude blood flow to end organs.

The recall covers 2,662,505 units distributed worldwide, including the United States and numerous international locations. The affected products are identified by catalog prefixes HNBR5.0 and HNBR6.0. Users should stop using the affected catheters and contact Cook Inc. for further instructions.

The recalled product

Product
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
Manufacturer
Cook Inc.
Category
Medical Device — Intravascular Catheter
Hazard
Affected units
2,662,505

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 HNBR5.0 and HNBR6.0 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 →

Related recalls

Same manufacturer · Cook Inc.

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Same hazard · device fracture

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