HeartWare Inc: Medical Device Recall in 2015 - (Recall #: Z-1604-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class I

Date Initiated: April 29, 2015

Date Posted: May 20, 2015

Recall Number: Z-1604-2015

Event ID: 71099

Reason for Recall:

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

Status: Ongoing

Product Quantity: 35

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.

Voluntary or Mandated:

Voluntary: Firm initiated