FDA Device Recall Z-1538-2017

Heartware · Miami Lakes, FL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: 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 .

Quantity: 8,343 US and 13,145 INTERNATIONAL

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)

Recall record

Recall number: Z-1538-2017
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: 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.
Recall initiated: 2017-02-03
Classified by FDA Center: 2017-04-26
FDA published: 2017-05-03
Recalling firm: Heartware
Firm location: Miami Lakes, FL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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