HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac

FDA device recall Z-1607-2014 · posted 2014-05-14 · Terminated

Recall details

Recalling firm

HeartWare Inc

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

DSQ

Quantity affected

32,349

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 Colum

Date initiated

2014-04-16

Date posted

2014-05-14

Date terminated

2016-10-03

Location

Miami Lakes, FL