TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 00142577 00142578 00142579 00142656 00142675 00142944 00142946 00142947 00142960 00142961
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Cardiac Assist, Inc
- Reason for Recall:
- Failure to prime due to an assembly error
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Product Codes/Lot Numbers:
Serial Numbers: 00142577 00142578 00142579 00142656 00142675 00142944 00142946 00142947 00142960 00142961
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1948-2020
Related Recalls
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.