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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76600

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

Open FDA event record

Event summary

Timeline bucket
February 03, 2017
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Heartware

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 HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use 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 (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

Z-1538-2017
Recall number
Z-1538-2017
Initiated
February 03, 2017
Classification
Class I
Status
Ongoing
Recalling firm
Heartware
Quantity
8,343 US and 13,145 INTERNATIONAL

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)

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

Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)

Code information

HeartWare HVAD System Controller Product numbers: 1401US, 1401XX, 1403US, 1407XX, and 1400 with the serial Number(s) lower than CON300000 HeartWare HVAD DC Adapter Product number: 1435 .

Distribution pattern

Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, , Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, UK, and Vietnam.