Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
FDA Recall Z-1813-2013 · Posted 2013-07-29
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Recalling FirmHeartWare Inc
Recall StatusTerminated
Product CodeDSQ
Date Initiated0013-05-16
Date Terminated2019-08-05
Product Quantity76 (US) and 82 (International)
Reason for Recall
Potential to electrostatic discharged (ESD)
Firm Action
HeartWare sent an Urgent Medical Device Correction Safety Notification letter on May 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to educate their patients about the HeartWare Controller and instructions for equipment handling stated in the IFU and recognized practices to avoid electrostatic discharge. The direct accounts were also told to scan and return the signed Acknowledgment Form via fax to 305-364-2665 or e-mail to [email protected].
Customers with questions were instructed to contact their HeartWare Representative or HeartWare Customers Service.
For questions regarding this recall call 305-364-1575.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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