HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015
- 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
- Reason for Recall:
- In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
Product Codes/Lot Numbers:
Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1832-2017
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