CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with Syner
Summary
The FDA issued a Class II for CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized H by Artivion, Inc. Reason: Grafts were found to have been approved, released, shipped and implanted with an invalid test results..
Details
Source
Device Recall
External ID
Z-2531-2024
Action Date
2024-08-14
Status
Ongoing
Category
device
Product Description
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Lot/Code Info: Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447
Quantity Affected: 2 valves
Reason for Recall
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Distribution
US Nationwide distribution in the states of CA, DC, FL, and NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-28
Company
Kennesaw, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Artivion, Inc has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Artivion, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Artivion, Inc have FDA actions?
Artivion, Inc has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2531-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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