Recall Z-1813-2013 ยท DSQ Ventricular (Assist) Bypass
HeartWare Inc
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
| Date | Jul 29, 2013 (initiated May 16, 13) |
| Status | Terminated |
| Reason | Potential to electrostatic discharged (ESD) |
| Root cause | Device Design |
| 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 quality@heartwareinc.com. Customers with questions were instru |
| Quantity | 76 (US) and 82 (International) |
| Distribution | 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, Ita |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.