--- title: "SynCardia Systems LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search SynCardia Systems LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/syncardia-systems-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # SynCardia Systems LLC recall records **1** reported ongoing 2 records in this archive. Latest source date Aug 1, 2023. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 1, 2023 FDA device enforcement ### [SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO](https://isitonrecall.com/recall/fda-device-z-0126-2024-syncardia-50cc-tah-t-clinical-ref-570500-sterile-eo/) Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. Class II Reported completed 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, Li... [Official source for SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0126-2024%22) Nov 2, 2022 FDA device enforcement ### [SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000](https://isitonrecall.com/recall/fda-device-z-1022-2023-syncardia-total-artificial-heart-system-70cc-500101-001-syncardia-total-artificial-heart-system-50cc/) Due to tears reported tears in the cannula due to wear and tear stress. Class II Reported ongoing Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA... [Official source for SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart Syste...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1022-2023%22) ## Reasons in these listed records - Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. - Due to tears reported tears in the cannula due to wear and tear stress. These examples come from this result page and are not a ranking of every recall reason. ## Checking SynCardia Systems LLC ### Is there a recall on syncardia systems llc right now? This archive contains 2 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search SynCardia Systems LLC](https://isitonrecall.com/check/?q=SynCardia%20Systems%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)