Medtronic HVAD Pump Implant Kits
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers
- 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:
- Heartware, Inc.
- Reason for Recall:
- There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.
- 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 Pump Implant Kits
Product Codes/Lot Numbers:
Product Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2478-2021
Related Recalls
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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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
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
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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