Recall Atlas
Drugs & medicalClass II

SynCardia Systems LLC recalls SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.

Read the official notice →
Date
2023-11-01
Country
United States
Brand
SynCardia Systems
Product
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Classification
Class II
Units
US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More SynCardia Systems recalls

  1. 2023-02-08
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    SynCardia Systems LLC recalls SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

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    FDA · DeviceSynCardia Systems LLCWorldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice →
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