Z-2271-2018Class II

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

Name: Z-2271-2018 Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Creator: CryoLife, Inc.
Published: 2018-05-14
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2018-05-14 / Terminated

FDA source

CryoLife, Inc. began a recall of Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO on 2018-05-14. FDA classified it as Class II and gives the reason as "Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2271-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-14
Posted: 2018-06-21
Terminated: 2019-03-29
Recalling firm: Artivion, Inc.
Product: Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Product code: OHA Heart Valve, More Than Minimally Manipulated Allograft
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.
FDA root cause: Under Investigation by firm
Action: The firm notified the consignees by letter on 05/14/2018.
Quantity in commerce: 1 unit
Distribution: AR, OH
Product codes and lots: Serial Number 10988203

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2271-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2271-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-21
Z-2272-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-21

Product code OHA

K092021UnclassifiedCryovalve Sg Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc. / cleared 2010-05-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)