FDA-Device2017-05-03Class I
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).
Heartware
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.
Sold states
Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.
Affected count
9 units
Manufactured in
14400 NW 60th Ave, N/A, Miami Lakes, FL, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1832-2017Don't want to check this manually?
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