Recall Z-1832-2017— Heartware
Class I · Ongoing
Class I FDA medical device recall by Heartware, initiated 2017-03-10. FDA's recall record names no specific 510(k) clearance for this event. 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).. 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..
- Recalling firm
- Heartware
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2017-03-10
- Firm location
- Miami Lakes, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.