Z-1832-2017Class I

HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit

Name: Z-1832-2017 HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit
Creator: Heartware
Published: 2017-03-10
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2017-03-10 / Open, Classified / root cause: design

FDA source

Heartware began a recall of HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been... on 2017-03-10. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1832-2017
Classification: Class I
Status: Open, Classified
Initiated: 2017-03-10
Posted: 2017-04-25
Recalling firm: HeartWare, Inc.
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).
Product code: DSQ Ventricular (Assist) Bypass
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.
Root cause tag: design
FDA root cause: Device Design
Action: HeartWare, now a part of Medtronic sent an Urgent Medical Device Recall letter on April 2015 and a follow-up letter on March 2017, to customers via overnight mail and/or email.. The letters identified the affected product, problem and actions to be taken. Customers were instructed to review the recall notice, forward the notice to individuals within their organization who need to be aware of the notice, complete, sign, and return the Acknowledgement Form . For questions contact your local HeartWare representative.
Quantity in commerce: 9 units
Distribution: Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.
Product codes and lots: Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1832-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1832-2017	Class I	Ongoing	Voluntary: Firm initiated	2017-05-03	2017-04-24

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)