Summary
The FDA issued a Class II for SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO by SynCardia Systems LLC. Reason: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy..
Details
Source
Device Recall
External ID
Z-0126-2024
Action Date
2023-11-01
Status
Completed
Category
device
Product Description
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Lot/Code Info: All Lots/ UDI: 00858000003053
Quantity Affected: 114 units
Reason for Recall
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Distribution
US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-01
Company
Tucson, AZ
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 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SynCardia Systems LLC has 2 FDA actions in our database, including 2 recalls.
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 (SynCardia Systems LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SynCardia Systems LLC have FDA actions?
SynCardia Systems LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0126-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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