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