🔍 RecallPedia

Medtronic HVAD Alarm Adapter, Product Number: 1450

Class I - Dangerous
🏥 Medical Devices Recalled: February 26, 2021 Heartware Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    All lot codes
  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:
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Medtronic HVAD Alarm Adapter, Product Number: 1450

Product Codes/Lot Numbers:

All lot codes

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1338-2021

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

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