CLASS II Device recall · Reported 27 Jun 2018 · FDA Enforcement Report

Cryovalve(R) SG Pulmonary Human Heart Valve recalled by CryoLife

CryoLife is recalling Cryovalve(R) SG Pulmonary Human Heart Valve, distributed in Arkansas, Ohio. The recall was initiated on 14 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number 10988203

Quantity recalled1 unit

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2271-2018
FDA event ID: 80199
Recalling firm: CryoLife, Kennesaw, GA
Classification: Class II
Status: Terminated
Recall initiated: 14 May 2018
FDA classified: 21 Jun 2018
Reported: 27 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

14 May 2018	Recall initiated by company
21 Jun 2018	Classified by FDA	+38 days
27 Jun 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

AR, OH

Arkansas Ohio

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Serial Number 10988203

Where was it sold?

AR, OH

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 80199

Reported	Class	Recall	Company	Reason	Where
27 Jun 2018	CLASS II	Cryopatch SG Pulmonary Human Cardiac Branch recalled by CryoLife	CryoLife	Other	AR, OH

More recalls from CryoLife

All 14

Reported	Class	Recall	Company	Reason	Where
22 Dec 2021Device	CLASS II	BioGlue Surgical Adhesive recalled by CryoLife	CryoLife	Hidden Drug Ingredients	GA
30 Dec 2020Device	CLASS II	CryoPatch SG Pulmonary Human Cardiac Patch recalled by CryoLife	CryoLife	Device Malfunction	Nationwide
30 Dec 2020Device	CLASS II	CryoValve SG Pulmonary Human Heart Valve recalled by CryoLife	CryoLife	Device Malfunction	Nationwide
1 May 2019Device	CLASS II	CryoPatch SG Pulmonary Hemi-Artery Patch recalled by CryoLife	CryoLife	Other	TX
3 Apr 2019Device	CLASS II	On-X Aortic Heart Valve with Anatomic Sewing Ring recalled by CryoLife	CryoLife	Labeling Errors	Nationwide

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28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/J/1RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide