🔍 RecallPedia

Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

Class I - Dangerous
🏥 Medical Devices Recalled: March 1, 2019 Thoratec Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 6675594 6675724 6675730 6677921 6696569 6696580 6696582 6696597 6696601 6696604 6703553 6703561 6703563 6703567 6721603 6721660 6721661 6721663 6721671 6721672 6721673 193496 193497 193499 193501 6425740 6425773 6449684 6675597 6449680 6425751 6425758 6425763 6425768 6449657 6449662 6512124 6677922 6425756 6425766 6425770 6449675 6449681 6449691 6675592 6677919 6677926 6694918 6696574 193500 193502 6425745 6425776 6449663 6449664 6449679 6449682 6449687 6449689 6677924 6677927 6692906 6693957 6696589 193495 193498 6449692 6675591 6675596 6692904 6696599 6512126 6675732 6675734 6675736 6692897 6449677 6692877
  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:
Thoratec Corp.
Reason for Recall:
Small black plastic particle was observed in the left ventricle during implant procedure.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

Product Codes/Lot Numbers:

Lot Numbers: 6675594 6675724 6675730 6677921 6696569 6696580 6696582 6696597 6696601 6696604 6703553 6703561 6703563 6703567 6721603 6721660 6721661 6721663 6721671 6721672 6721673 193496 193497 193499 193501 6425740 6425773 6449684 6675597 6449680 6425751 6425758 6425763 6425768 6449657 6449662 6512124 6677922 6425756 6425766 6425770 6449675 6449681 6449691 6675592 6677919 6677926 6694918 6696574 193500 193502 6425745 6425776 6449663 6449664 6449679 6449682 6449687 6449689 6677924 6677927 6692906 6693957 6696589 193495 193498 6449692 6675591 6675596 6692904 6696599 6512126 6675732 6675734 6675736 6692897 6449677 6692877

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1203-2019

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