Product Safety Recalls

Product Recall Tracker

SynCardia Systems LLC Recall 92930

Description: SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

SynCardia Systems LLC Recall 92930 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0126-2024
Event ID92930
Event DescriptionSynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Product TypeDevices
DistributionUS: 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
Quantity114 units
Recall ReasonArtificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Device Classification20231101
Device Code InfoAll Lots/ UDI: 00858000003053
Center Classification Date20231020
Recall Initiation Date20230801
Recalling FirmSynCardia Systems LLC
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.