CLASS I ONGOING Device recall · Reported 20 May 2015 · FDA Enforcement Report

Ventricular Assist System (HVAD) Pump Driveline Splice Kit recalled

HeartWare is recalling HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit, distributed nationwide in the US. The recall was initiated on 29 Apr 2015 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesCatalog #: 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

Quantity recalled35

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1604-2015
FDA event ID: 71099
Recalling firm: HeartWare, Miami Lakes, FL
Classification: Class I
Status: Ongoing
Recall initiated: 29 Apr 2015
FDA classified: 14 May 2015
Reported: 20 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

29 Apr 2015	Recall initiated by company
14 May 2015	Classified by FDA	+15 days
20 May 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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).

Where it was distributed

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.

Nationwide Florida Kentucky Missouri New York Tennessee Texas

Questions about this recall

Is Ventricular Assist System (HVAD) Pump Driveline Splice Kit recalled?

Yes. HeartWare recalled Ventricular Assist System (HVAD) Pump Driveline Splice Kit on 29 Apr 2015. The recall is Class I and its status is Ongoing. Recall number Z-1604-2015.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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