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SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO recallZ-0126-2024 · SynCardia Systems LLC · initiated Aug 1, 2023

Completed

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from SynCardia Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Other

What the company is doing

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

Recall details

Recall number
Z-0126-2024
Status
Completed
Initiated by the company
Aug 1, 2023
Posted by the FDA
Oct 20, 2023
Recalling firm
SynCardia Systems LLC
Quantity
114 units
Product code
LOZ
FDA submissions
P030011
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

Product description

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

Code information (models, lots, serial numbers)

All Lots/ UDI: 00858000003053

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

8 devices cleared under P030011 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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