HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the Hear

FDA device recall Z-0422-2010 · posted 2009-11-24 · Terminated

Recall details

Recalling firm

Thoratec Corp

Reason for recall

Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some cases dislodged from the battery clip housing. The problem affects HeartMate 12V SLA Battery Clips including those used for the HeartMate II LVAS and HeartMate XVE systems. If not detected and handled

Action taken

Firm has issued a notification letter to consignees, dated October 14, 2009 asking them to return proof of receipt, and to remove all affected unused devices from stock, and asking ongoing patients to return to hospitals for inspection, replacement if needed, and retraining on the process of switching power sources and safely switching to a back-up system controller. Contact Thoratec Customer Services at 1-800-456-1477 for any questions or concerns about this issue.

Root cause

Other

Status

Terminated

Product code

DSQ

Quantity affected

8,194 battery clips

Distribution

Worldwide - USA- AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the District Columbia. Internationally to Au

Date initiated

2009-10-14

Date posted

2009-11-24

Date terminated

2011-04-18

Location

Pleasanton, CA