Class 2 Device Recall SynCardia 50cc TAHt

• Date Initiated by Firm: August 01, 2023
• Date Posted: October 20, 2023
• Recall Status: Completed
• Recall Number: Z-0126-2024
• Recall Event ID: 92930
• PMA Number: P030011
• Product Classification: Artificial heart - Product Code LOZ
• Product: SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
• Code Information: All Lots/ UDI: 00858000003053
• FEI Number: 3003761017
• Recalling Firm/ Manufacturer: SynCardia Systems LLC; 1992 E Silverlake Rd; Tucson AZ 85713-3865
• For Additional Information Contact: Elizabeth OEI; 203-807-0965
• Manufacturer Reason for Recall: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• PMA Database: PMAs with Product Code = LOZ