Agency classClass IIOur severity:High FDA (Devices)·Z-0135-2014·Announced 2013-11-13

Edwards Lifesciences Recalls Aortic Perfusion Cannulas Due to Cracks

Edwards Lifesciences is recalling two lots of aortic perfusion cannulas because cracks were found in the t-connectors during product evaluation.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (cracks) in a medical device used during surgery, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Edwards Lifesciences, LLC is recalling two lots of Dispersion Aortic Perfusion Cannulas with Duraflo Coating. The recall involves 140 units of the sterile, single-use devices, which are intended for perfusion of the ascending aorta during short-term cardiopulmonary bypass procedures.

The recall was initiated due to reported complaints involving cracks in the t-connector of the devices. These cracks were confirmed during product evaluation. The specific lot number is 59261626, with an expiration date of 06/01/15. The products were distributed nationwide.

Healthcare providers and patients should stop using the affected cannulas and contact Edwards Lifesciences for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product: Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures.…
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Cardiovascular
Hazard: structural-defect
Affected units: 140

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)

Lot number 59261626 expiry 06/01/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Edwards Lifesciences, LLC 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 2 products in this recall →

Same manufacturer · Edwards Lifesciences, LLC

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Same hazard · structural defect