Device product
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).
Z-1832-2017
Product summary
- Firm
- Heartware
- Event
- Event 76807
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 9 units
- Official record key
device-enforcement:Z-1832-2017
Official wording
Reason: 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.
Code information: Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015
Distribution pattern: Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.
Derived failure modes
-
Unknown
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.