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HeartWare HVAD Pump Implant Kit (Heartware Ventricular… recallZ-1607-2014 · HeartWare Inc · initiated Apr 16, 2014

Class II Terminated All recalls posted in May 2014

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

Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.

FDA root cause category: Under Investigation by firm

What the company is doing

HeartWare sent an Urgent Medical Device Correction letter dated April 30, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to familiarize themselves with the letter and review their Patient Manual about proper power management. Discuss with their VAD Coordinator any questions they may have about the HeartWare System or the letter. Always keep two (2) power sources connected to your controller; never leave your controller connected to only one (1) power source except while briefly switching to another power source. " Review the recommended practices for power management provided later in this letter. If a battery shows any of the abnormal battery behaviors described, stop using that battery and contact your VAD Coordinator immediately to replace it. Customers were instructed to confirm that they have received and understood the information. Sign and return the enclosed Confirmation form as soon as they can to HeartWare in the prepaid self-addressed envelope or by fax to 1-305-364-2665. For questions customers were instructed to contact their doctor or VAD coordinator. For questions regarding this recall call 305-364-1575.

Recall details

Recall number
Z-1607-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 16, 2014
Posted by the FDA
May 14, 2014
Recalling firm
HeartWare Inc
Quantity
32,349
Product code
DSQ
FDA submissions
P100047
Distribution
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia and Internationally to Canada, Dominican Republic, Australia, Belgium, Italy, Germany, New Zeland, South Afica, Japan, Venezuela, Czech Republic, France, Switzerland, Brazil, UK, Saui Arabia, Taiwan, Slovakia, Luxemburg, Hong Kong, Lebano, India, Chile, Oldenburg, Israel, Netherlands, Croatia, Egypt, Turkey, Malaysia, Norway, Greece, Spain, Lithuania, Korea, Singapore, Poland, and Argentina.

Product description

HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

Code information (models, lots, serial numbers)

Catalog# USA:1650 // OUS: 1650, 1650-DE All HeartWare Battery Serial Numbers

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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