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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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... — Recall Details · AllClear