Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3108-2017·Announced 2017-09-13

CryoLife On-X Heart Valve Recall Due to Device Mix-Up

CryoLife is recalling five On-X Prosthetic Heart Valves because a return authorization error caused them to be redistributed and implanted in two patients.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a procedural error (mix-up) resulting in the implantation of devices, but the source text does not report any specific injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity score.

Plain-English summary

CryoLife, Inc. is recalling five units of the On-X Prosthetic Heart Valve with Gelweave Valsalva Graft. The recall was initiated because a mix-up in the Return Goods Authorization (RGA) process led to the devices being redistributed and subsequently implanted in two patients.

The affected devices are identified by Model No. ONXAAP and Serial Nos. 3260716, 3718302, 3190113, 3194122, and 3634902. These single-use medical devices are indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position, specifically in cases involving an ascending aortic aneurysm or other associated aortic disease.

The recall is limited to the state of Illinois. Patients who have had these specific devices implanted should contact their healthcare provider for further evaluation and instructions.

The recalled product

Product: On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic…
Manufacturer: CryoLife, Inc.
Category: Medical Device — Cardiovascular
Hazard: device-mix-up
incorrect-implantation
Affected units: 5

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 (5)

Model No. ONXAAP
Serial No. 3260716
3718302
3190113
3194122 and 3634902

Distribution

Distributed in 1 state:

Same manufacturer · CryoLife, Inc.

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