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HeartWare Ventricular Assist System (HVAD) recallZ-1731-2015 · HeartWare Inc · initiated Apr 29, 2015

Class I Open, Classified All recalls posted in June 2015

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

Complaints with the HVAD Internal Controller Alarm Battery failures.

FDA root cause category: Device Design

What the company is doing

Urgent Medical Device Correction letters were sent to customers. The letter identified the affected product, as well as the reason for the recall and risks involved. HeartWare requests that customers review and familiarize themselves with the letter and "Patient Communication," and ensure that all necessary individuals are aware. Patients currently being supported by the device should be identified and given the "Patient Communication." A HeartWare representative can provide assistance with that process if needed. The "Acknowledgement and Completion Form" should be completed, signed, and returned within 30 days of the receipt of the letter. Customers can contact their local HeartWare representative with questions or concerns. Clinical Support personnel are also available at 1-888-494-6365.

Recall details

Recall number
Z-1731-2015
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Apr 29, 2015
Posted by the FDA
Jun 13, 2015
Recalling firm
HeartWare Inc
Quantity
3,747 curently implanted
Product code
DSQ
FDA submissions
P100047
Distribution
Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.

Product description

HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

Code information (models, lots, serial numbers)

Serial #: ALL HeartWare HVAD systems currently in use.

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

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