HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the b

FDA device recall Z-1228-2014 · posted 2014-03-21 · Terminated

Recall details

Recalling firm

Thoratec Corporation

Reason for recall

Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

Action taken

Thoratec sent an Urgent Medical Device Correction letter dated March 4, 2014 to all affected customers. The letter was sent via e-mail. All distributors outside of the USA and Canada to whom affected product has been distributed have been notified of this field correction notice and have been provided copies of the Customer Letter to forward to their customers. The letter identified the affected product , problem and actions to be taken. Customers were requested to complete and sign the attached Acknowledgement Form and return it to Thoratec via fax (925-847-8571) or e-mail a scanned copy to customer.service@thoratec.com. For questions call 1-800-528-2577.

Root cause

Device Design

Status

Terminated

Product code

DSQ

Quantity affected

4120

Distribution

Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and

Date initiated

2014-03-04

Date posted

2014-03-21

Date terminated

2015-08-27

Location

Pleasanton, CA