Z-1832-2017 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2017
- Initiation Date
- March 10, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product 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).
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.
Code Information
Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015