CryoLife, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2271-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

Product Classification:

Class II

Date Initiated: May 14, 2018

Date Posted: June 27, 2018

Recall Number: Z-2271-2018

Event ID: 80199

Reason for Recall:

Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial Number 10988203

Distribution Pattern:

AR, OH

Voluntary or Mandated:

Voluntary: Firm initiated