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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73636

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 07, 2016
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Heartware, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1887-2016
Recall number
Z-1887-2016
Initiated
January 07, 2016
Classification
Class I
Status
Terminated
Recalling firm
Heartware, Inc.
Quantity
18, 631

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Heartware Ventricular Assist System Battery Cell experiencing premature depletion.

Code information

Serial numbers ranging BAT000001 to BAT199999.

Distribution pattern

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.

Field note

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