Z-0126-2024Class II

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

Name: Z-0126-2024 SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Creator: SynCardia Systems LLC
Published: 2023-08-01
License: https://open.fda.gov/license/

SynCardia Systems LLC / initiated 2023-08-01 / Completed

FDA source

SynCardia Systems LLC began a recall of SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO on 2023-08-01. FDA classified it as Class II and gives the reason as "Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0126-2024
Classification: Class II
Status: Completed
Initiated: 2023-08-01
Posted: 2023-10-20
Recalling firm: SynCardia Systems LLC
Product: SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Product code: LOZ Artificial Heart
Reason for recall: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
FDA root cause: Other
Action: On August 22, 2023, SynCardia issued an Urgent Medical Device Correction Notification to all affected consignees via Email. SynCardia asked consignees to take the following actions: 1. You may continue to use the device while the change undergoes FDA review for safety and effectiveness. 2.Ensure that all medical professionals in your institution are informed of this Urgent Medical Device Correction. 3. Please complete the Customer Acknowledgement Form and return it via email to SynCardia Systems, LLC, within five business days of receipt of this letter. 4.For patients with implanted devices affected by this correction, monitor patients closely and take appropriate actions you believe necessary if any issues arise. 5. Adverse reactions or quality problems experienced with this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Complete and submit the report online: www.fda.gov/medwatch/report.htm " Regular Mail or Fax: Download the form from www.fda.gov/medwatch/getforms.htm or call 1-800-322-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Quantity in commerce: 114 units
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
Product codes and lots: All Lots/ UDI: 00858000003053

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0126-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0126-2024	Class II	Completed	Voluntary: Firm initiated	2023-11-01	2023-10-20

Product code LOZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)