The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0652-2021·Announced 2020-12-30

CryoLife Recalls CryoValve SG Pulmonary Heart Valves Due to Microbial Test Failures

CryoLife, Inc. is recalling three CryoValve SG Pulmonary Human Heart Valves because post-processing microbial culture tests failed for allografts processed with the same TRIS saline solution lot.

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 involves a high-risk medical device (heart valve) with a potential contamination hazard (microbial culture failures) but no reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CryoLife, Inc. is recalling three units of the CryoValve SG Pulmonary Human Heart Valve. The affected units are identified by Model/Catalog Number SGPV00 and Serial Numbers 11685214, 11685554, and 11682491. The UDI for the product is 00877234000447.

The recall was initiated after it was discovered on November 10, 2020, that post-processing microbial culture tests failed for other allografts. These other allografts were processed using a specific lot of TRIS saline solution that was also used in the processing of the recalled CryoValve SG units. The product is a cryopreserved human heart valve distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.

The affected units were distributed nationwide to Georgia, Arizona, Texas, Missouri, and Oklahoma. The source text does not specify which hospitals or facilities received the units, nor does it report any illnesses or injuries associated with the use of these specific valves. Healthcare providers and facilities that may have received these units should contact CryoLife, Inc. for further instructions on how to handle the recalled product.

The recalled product

Product
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic…
Manufacturer
CryoLife, Inc.
Category
Medical Device — Implantable Heart Valve
Hazard
Affected units
3

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 (3)

  • Model/Catalog Number: SGPV00 Serial Numbers: 11685214
  • 11685554
  • and 11682491 UDI: 00877234000447

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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 →

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