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Recall Observatory FDA recall evidence

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-1604-2015

April 29, 2015

Class I

Product summary

Firm
HeartWare Inc
Event
Event 71099
Status
Ongoing
Classification
Class I
Quantity
35
Official record key
device-enforcement:Z-1604-2015

Official wording

Reason: Failures of the splice repair kit if exposed to excessive force.

Code information: Catalog #: ASY00116: HVAD Pump Driveline Splice Kit Lot #'s 532770, 567949, 480786, 483769, 490692, 539664, and 598189 and Catalog #: ASY00281: HVAD Pump Driveline Splicekit; Large OD Sheath Lot #'s 654090, 672401, 678800, 690423, 833963, 873159, and 880816

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failures of the splice repair kit if exposed to excessive force.