CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report
CryoValve SG Pulmonary Human Heart Valve, SGPV00 recalled by Artivion
Artivion is recalling CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart, distributed nationwide in the US. The recall was initiated on 28 May 2024 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-2531-2024
- FDA event ID
- 94909
- Recalling firm
- Artivion, Kennesaw, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2024
- FDA classified
- 8 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 28 May 2024 | Recall initiated by company | |
| 8 Aug 2024 | Classified by FDA | +72 days |
| 14 Aug 2024 | 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
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Product as listed by the FDA
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Where it was distributed
US Nationwide distribution in the states of CA, DC, FL, and NY.
Questions about this recall
Why was it recalled?
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Which lots are affected?
Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447
Where was it sold?
US Nationwide distribution in the states of CA, DC, FL, and NY.
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 94909This product is part of a recall event; the main page for the event is CryoPatch SG Pulmonary Human Cardiac Hemi-Artery recalled by Artivion.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CryoPatch SG Pulmonary Human Cardiac Hemi-Artery recalled by Artivion | Artivion | Other | Nationwide |
More recalls from Artivion
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CryoPatch SG Pulmonary Human Cardiac Hemi-Artery recalled by Artivion | Artivion | Other | Nationwide |
| Device | CLASS II | CryoValve SG Cryopreserved Pulmonary Human Heart Valve recalled | Artivion | Other Bacterial Contamination | Nationwide |
Other Heart & Vascular Devices recalls
All 6,217| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS II | System (RED 62 Reperfusion Catheter) recalled by Penumbra | Penumbra | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |