CLASS I Device recall · Reported 20 Jul 2016 · FDA Enforcement Report

Ventricular Assist System: HeartWare Battery, Lithium Ion, 8 V recalled

Heartware is recalling HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 8 V, distributed nationwide in the US. The recall was initiated on 7 Jan 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesSerial numbers ranging BAT000001 to BAT199999.

Quantity recalled18, 631

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-1887-2016
FDA event ID: 73636
Recalling firm: Heartware, Miami Lakes, FL
Classification: Class I
Status: Terminated
Recall initiated: 7 Jan 2016
FDA classified: 8 Jul 2016
Reported: 20 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

7 Jan 2016	Recall initiated by company
8 Jul 2016	Classified by FDA	+183 days
20 Jul 2016	Published in enforcement report	+12 days

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

Reason for recall

Heartware Ventricular Assist System Battery Cell experiencing premature depletion.

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: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.

Where it was distributed

US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.

Nationwide Alabama Arizona California Colorado Connecticut Delaware Florida Georgia Iowa Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Missouri Mississippi North Carolina Nebraska

Questions about this recall

Is Ventricular Assist System: HeartWare Battery, Lithium Ion, 8 V recalled?

Yes. Heartware recalled Ventricular Assist System: HeartWare Battery, Lithium Ion, 8 V on 7 Jan 2016. The recall is Class I and its status is Terminated. Recall number Z-1887-2016.

Why was it recalled?

Heartware Ventricular Assist System Battery Cell experiencing premature depletion.

Which lots are affected?

Serial numbers ranging BAT000001 to BAT199999.

Where was it sold?

US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.

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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13 Dec 2023Device	CLASS II	1104CA-Clin - Hvad (HeartWare Ventricular Assist Device) Pump recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled	Heartware	Sterility	FL
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13 Dec 2023Device	CLASS II	Pump MCS1705PU Hvad (HeartWare Ventricular Assist Device) recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled	Heartware	Sterility	FL

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