The FDA gave HeartSine’s Samaritan defibrillator recall Class I status over concerns that battery issues could lead to patient injury or death.
The Samaritan 300/300P public access defibrillators, which were found to intermittently turn off and on, may be unable to deliver therapy during a cardiac event due to the battery defects.
The affected products include those with the following serial numbers, which were manufactured and distributed from 08/01/2004 to 01/31/2011:
0400000501 to 0700032917
08A00035000 to 10A0070753
10C00200000 to 10C00210106
U.K. medical device maker HeartSine Technologies earlier this month launched a global correction of its Samaritan defibrillators after finding that the devices failed to provide therapy due to a pair of battery defects.
There were no deaths or injuries reported within this issue. HeartSine has not yet conclusively determined whether 5 reported deaths were related to the battery issues, according to the FDA comments.