HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: HW24101, HW24102, HW24103, HW24104, HW24755, HW24763
- 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:
- Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
- 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 Kit, REF 1104CA-CLIN
Product Codes/Lot Numbers:
Serial Numbers: HW24101, HW24102, HW24103, HW24104, HW24755, HW24763
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0747-2023
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