Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

FDA device recall Z-1813-2013 · posted 2013-07-29 · Terminated

Recall details

Recalling firm

HeartWare Inc

Reason for recall

Potential to electrostatic discharged (ESD)

Action taken

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 instructed to contact their HeartWare Representative or HeartWare Customers Service. For questions regarding this recall call 305-364-1575.

Root cause

Device Design

Status

Terminated

Product code

DSQ

Quantity affected

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, B

Date initiated

0013-05-16

Date posted

2013-07-29

Date terminated

2019-08-05

Location

Miami Lakes, FL