SynCardia recalls 50cc TAH-t artificial hearts with unapproved epoxy resin. This poses a risk of serious injury if not corrected by FDA review. Affected units have specific lot numbers.
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
SynCardia is recalling its 50cc TAH-t artificial hearts because they contain epoxy resin that hasn't been reviewed by the FDA for safety. This could lead to serious injury if the device is used without proper regulatory approval.
The artificial hearts contain epoxy resin that has not been reviewed by the FDA for safety and efficacy. This means the resin could cause harm if the device is used without proper regulatory oversight.
Patients with artificial hearts who own the recalled model are affected. Those with the specific lot numbers are at risk due to the unapproved epoxy resin.
Check for the product name 'SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO' and lot numbers starting with 00858000003053.
Identify the lot number on your device to confirm if it matches the recalled units (00858000003053).
The recall states the epoxy resin has not been reviewed by the FDA for safety and efficacy, but the exact risk level is not specified in the notice.
The recall record does not provide specific action steps beyond checking the lot number. Contact SynCardia directly for further guidance.
Look for the product name 'SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO' and lot numbers starting with 00858000003053.
We’ve drafted a message you can send SynCardia to request your refund or repair — edit it as you like.
Subject: Recall Z-0126-2024 — SynCardia SynCardia Hello, I own a SynCardia that is covered by recall Z-0126-2024 from SynCardia. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
