Heartware: Medical Device Recall in 2017 - (Recall #: Z-1832-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

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: March 10, 2017

Date Posted: May 3, 2017

Recall Number: Z-1832-2017

Event ID: 76807

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 9 units

Code Information:

Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.

Voluntary or Mandated:

Voluntary: Firm initiated