CLASS II Device recall · Reported 30 Dec 2020 · FDA Enforcement Report
CryoValve SG Pulmonary Human Heart Valve recalled by CryoLife
CryoLife is recalling CryoValve SG Pulmonary Human Heart Valve, distributed nationwide in the US. The recall was initiated on 10 Nov 2020 and the FDA has classified it as Class II.
Check your package
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-0652-2021
- FDA event ID
- 86890
- Recalling firm
- CryoLife, Kennesaw, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2020
- FDA classified
- 21 Dec 2020
- Reported
- 30 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 10 Nov 2020 | Recall initiated by company | |
| 21 Dec 2020 | Classified by FDA | +41 days |
| 30 Dec 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135¿C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.
Where it was distributed
Distributed nationwide to GA, AZ, TX, MO, and OK.
Questions about this recall
Why was it recalled?
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
Which lots are affected?
Model/Catalog Number: SGPV00 Serial Numbers: 11685214, 11685554, and 11682491 UDI: 00877234000447
Where was it sold?
Distributed nationwide to GA, AZ, TX, MO, and OK.
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 86890| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CryoPatch SG Pulmonary Human Cardiac Patch recalled by CryoLife | CryoLife | Device Malfunction | Nationwide |
More recalls from CryoLife
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BioGlue Surgical Adhesive recalled by CryoLife | CryoLife | Hidden Drug Ingredients | GA |
| Device | CLASS II | CryoPatch SG Pulmonary Human Cardiac Patch recalled by CryoLife | CryoLife | Device Malfunction | Nationwide |
| Device | CLASS II | CryoPatch SG Pulmonary Hemi-Artery Patch recalled by CryoLife | CryoLife | Other | TX |
| Device | CLASS II | On-X Aortic Heart Valve with Anatomic Sewing Ring recalled by CryoLife | CryoLife | Labeling Errors | Nationwide |
| Device | CLASS II | CryoPatch SG Pulmonary Hemi-Artery, 1 graft recalled by CryoLife | CryoLife | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,227| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NaviFlex LW Pusher recalled by Boston Scientific | Boston Scientific | Other | Nationwide |
| Device | CLASS II | JenaValve Trilogy Delivery Catheter, Size recalled | Jenavalve Technology | Other | Nationwide |
| Device | CLASS II | Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack recalled | Sarnova HC | Other | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | JenaValve Trilogy Delivery Catheter, Size recalled | Jenavalve Technology | Other | Nationwide |