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HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the drivel
Recalled May 20, 2015 · FDA recall Z-1604-2015 · HeartWare
Hazard
Failures of the splice repair kit if exposed to excessive force. · FDA Class I
Units
35
Sold at
Worldwide Distribution - US Nationwide in the states of FL, KY, MO, NY, TN,TX, and the countries of: Canada, Germany, Italy, Netherlands, Turkey and United Kingdom.
Description
Failures of the splice repair kit if exposed to excessive force.
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).
Manufacturer(s)
HeartWare Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →