Z-1604-2015Class I

HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit

Name: Z-1604-2015 HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit
Creator: HeartWare Inc
Published: 2015-04-29
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2015-04-29 / Open, Classified / root cause: design

FDA source

HeartWare Inc 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 2015-04-29. FDA classified it as Class I and gives the reason as "Failures of the splice repair kit if exposed to excessive force". 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-1604-2015
Classification: Class I
Status: Open, Classified
Initiated: 2015-04-29
Posted: 2015-05-14
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: Failures of the splice repair kit if exposed to excessive force.
Root cause tag: design
FDA root cause: Device Design
Action: HeartWare, Inc. sent an Urgent Medical Device Correction letter to all affected consignees on May 11, 2015. The letter identified the affected product, problem, and actions to be taken by the consignees. The firm requested that consignees: 1) review the notice and the Patient Communication contents, 2) forward the notice to individuals within their organization who need to be aware of the notice, 3) identify patients that are currently on support and have undergone a driveline splice repair, 4) distribute the Patient Communication to the affected patients in person, 5) continue to reinforce the messages described in the notice with patients who have experienced a splice repair during their regularly scheduled appointments, 6) complete, sign, and return the "Acknowledge and Completion Form to HeartWare within 30 days of receipt of the letter. Should any questions or concerns arise, please contact there local HeartWare representative. Their 24-hour Clinical Support personnel are also available at 1 (888) 494-6365.
Quantity in commerce: 35
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1604-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1604-2015	Class I	Ongoing	Voluntary: Firm initiated	2015-05-20	2015-05-14

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)