FDA Medical Device Recalls (openFDA)
SynCardia Systems LLC: SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
- Recall number
- Z-0126-2024
- Recalling firm
- SynCardia Systems LLC
- Product
- SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
- Status
- Completed
- Initiated
- 2023-08-01
- Posted
- 2023-10-20
- Terminated
- not on file
- Reason
- Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
- 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
- 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
- Lot, serial or model codes
- All Lots/ UDI: 00858000003053
- 510(k) numbers
- not on file
- PMA numbers
- ["P030011"]
- Product code
- LOZ
- Firm FEI
- 3003761017
- Firm city
- Tucson
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28