Z-1887-2016Class I

HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and...

Name: Z-1887-2016 HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and...
Creator: Heartware, Inc.
Published: 2016-01-07
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2016-01-07 / Terminated / root cause: software

FDA source

Heartware, Inc. began a recall of 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... on 2016-01-07. FDA classified it as Class I and gives the reason as "Heartware Ventricular Assist System Battery Cell experiencing premature depletion". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1887-2016
Classification: Class I
Status: Terminated
Initiated: 2016-01-07
Posted: 2016-07-08
Terminated: 2020-03-27
Recalling firm: HeartWare, Inc.
Product: 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.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
Root cause tag: software
FDA root cause: Software design
Action: The firm, HeartWare, sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 7, 2016, to all their consignees informing them that of the HeartWare HVAD Battery recall (device exchange). The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Promptly complete the attached Acknowledgment Form and return it to HeartWare no later than 30 days from the date of this letter via email to [email protected] or provide verbal Acknowledgement by calling Customer Service line , 1(844)491-7871; or fax to +1 (844)721-3044.. 2. Immediately identify and quarantine affected batteries in hospital inventory, and apply a RECALLED PRODUCT DO NOT USE sticker (provided with this notice) as illustrated below. Replace quarantined inventory AC Adapters and batteries by requesting a Return Goods Authorization (RGA) through a qualified representative or directly through HeartWare Customer Service (via telephone 1-877-367-4823 or email [email protected]). A qualified representative will update the Controller software for affected Controller units in inventory. 3. Identify, collect and quarantine affected product in patient possession. Arrange for current patients to bring their Batteries to a clinic appointment as soon as possible, (at least within the next three months), with urgency dependent upon individual patient circumstances. During their regularly scheduled appointment, a qualified representative will assist with quarantining and replacing affected product. Apply a RECALLED PRODUCT DO NOT USE sticker as illustrated on affected batteries. Replace affected patient product using hospital inventory, and replace consumed hospital inventory by requesting an RGA as described above. 4. Return affected product to HeartWare. Your HeartWare representative will assist you with returning affected product to HeartWare. 5. Complete and return the attached Completion Form no later than 6 months from the date of this let
Quantity in commerce: 18, 631
Distribution: 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.
Product codes and lots: Serial numbers ranging BAT000001 to BAT199999.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1887-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1887-2016	Class I	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-08

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)