SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
This recall has been completed (originally issued October 20, 2023).
- Company
- Syncardia Systems Llc
- Recall Initiated
- August 1, 2023
- Posted
- October 20, 2023
- Recall Number
- Z-0126-2024
- Quantity
- 114 units
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
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
Lot / Code Info
All Lots/ UDI: 00858000003053
Root Cause
Other
Action Taken
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