🔍 RecallPedia

Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

Class I - Dangerous
🏥 Medical Devices Recalled: April 3, 2020 Heartware Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    GTIN 00888707000147, All lot numbers in distribution
  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:
Heartware, Inc.
Reason for Recall:
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

Product Codes/Lot Numbers:

GTIN 00888707000147, All lot numbers in distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2059-2020

Related Recalls

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205

Heartware

Class I - Dangerous

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Oct 31, 2023 Implants & Prosthetics View Details →