CryoLife Recalls Cryovalve SG Pulmonary Human Heart Valve
CryoLife, Inc. is recalling one unit of the Cryovalve SG Pulmonary Human Heart Valve because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or those not explicitly ruled out as low-risk, are categorized as Severe (4).
Plain-English summary
CryoLife, Inc. is recalling one unit of the Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO, Serial Number 10988203. The device was distributed to facilities in Arkansas and Ohio.
The recall was initiated because final autopsy and toxicology reports indicated the presence of morphine in the urine of the donor. The device met FDA and AATB eligibility criteria at the time of distribution.
Healthcare providers and facilities that received this specific unit should stop using it and contact CryLife, Inc. for further instructions.
The recalled product
- Product
- Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
- Manufacturer
- CryoLife, Inc.
- Category
- Medical Device — Heart Valve
- Hazard
- Affected units
- 1
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)
- Serial Number 10988203
Distribution
Part of a larger recall action
This product is one of 2 recalled by CryoLife, 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 2 products in this recall →Related recalls
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