Skip to content

HeartWare Ventricular Assist System Controller recallZ-0005-2017 · Heartware, Inc. · initiated Jun 8, 2016

Class I Terminated All recalls posted in October 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Heartware, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Loose connector ports in controller body.

FDA root cause category: Device Design

What the company is doing

HeartWare sent an Urgent Medical Device Correction letter dated June 8, 2016, to all affected customers, HeartWare advised clinicians to remind patients to follow unit instructions and water avoidance, and to regularly schedule appointments to check the integrity of the unit and to be cautious with connectors when inspecting connectors. Clinicians were also instructed to send back the enclosed "Acknowledgement Form" within 30 days and to forward the message to necessary individuals within their organization. Customers with questions were instructed to contact their local HeartWare representative. For questions regarding this recall call 305-364-1575.

Recall details

Recall number
Z-0005-2017
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Jun 8, 2016
Posted by the FDA
Oct 17, 2016
Recalling firm
Heartware, Inc.
Quantity
4235 Worldwide, 7272 units in U.S.
Product code
DSQ
FDA submissions
P100047
Distribution
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, 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 countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.

Product description

HeartWare Ventricular Assist System Controller Product Usage: 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 HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

Code information (models, lots, serial numbers)

All Heartware Controllers manufactured after September 2014. US Model No: 1400, 1401XX, 1403US.  International Model No: 1400, 1401XX, 1407XX.

Other devices under the same FDA submission

33 devices cleared under P100047 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page