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

FDA device recall Z-0126-2024 · posted 2023-10-20 · Completed

Recall details

Recalling firm

SynCardia Systems LLC

Reason for recall

Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.

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

Root cause

Other

Status

Completed

Product code

LOZ

Quantity affected

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 Austr

Date initiated

2023-08-01

Date posted

2023-10-20

Location

Tucson, AZ