FDAMarch 17, 2015device
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.
What to do
FDA enforcement status: Terminated
Brands named
medtronic inc cardiac rhythm disease managementmedtronicmedtronic inc
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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