FDAFDA · Food and drugs·Recall number Z-1832-2017
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).
Published May 3, 2017 · Recall initiated: March 10, 2017
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Heartware
- Distributor
- Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.
- Lot
- Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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