Recall Z-0126-2024 ยท LOZ Artificial Heart
SynCardia Systems LLC
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
| Date | Oct 20, 2023 (initiated Aug 1, 2023) |
| Status | Completed |
| 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.