Agency classClass IIOur severity:Severe FDA (Devices)·Z-2611-2016·Announced 2016-08-31

Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters

Cook Inc. is recalling 532,395 Beacon Tip Royal Flush Plus High-Flow Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

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 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 meets the criteria for a Severe rating.

Plain-English summary

Cook Inc. is recalling 532,395 units of the Beacon Tip Royal Flush Plus High-Flow Catheter. These intravascular diagnostic catheters are intended for use in angiographic procedures by physicians trained in angiographic techniques. The recall covers all lots with catalog prefixes HNR5.0 and was distributed nationwide in the US and internationally to numerous countries.

The recall is being conducted 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, 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 occlude blood flow to end organs.

Healthcare providers and facilities that have purchased these catheters should stop using them and contact Cook Inc. for instructions on return or replacement. The source text does not specify a particular consumer action for the general public, as these are professional medical devices.

The recalled product

Product: Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths…
Manufacturer: Cook Inc.
Category: Medical Device — Intravascular Catheter
Hazard: device-fracture
embolization
vascular-occlusion
Affected units: 532,395

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 HNR5.0 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 →

Same manufacturer · Cook Inc.

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Same hazard · device fracture