FDA Device Recall Z-1832-2017
Heartware · Miami Lakes, FL
Class I — life-threatening Ongoing
Device
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.
Recall record
- Recall number
Z-1832-2017- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.
- Recall initiated
- 2017-03-10
- Classified by FDA Center
- 2017-04-24
- FDA published
- 2017-05-03
- Recalling firm
- Heartware
- Firm location
- Miami Lakes, FL
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.