🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: August 1, 2023 SynCardia Systems Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    All Lots/ UDI: 00858000003053
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
SynCardia Systems LLC
Reason for Recall:
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
completed

Product Information

Full Description:

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

Product Codes/Lot Numbers:

All Lots/ UDI: 00858000003053

Distribution:

Distributed in: US, FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0126-2024

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Class I - Dangerous

SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function.

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