FDA Device recall Z-1356-2015
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392
- FDA Device
- Class II
- terminated
- Published 2015-04-08
On 2015-04-08 the FDA classified a Class II recall of Medtronic Dual Chamber Temporary External Pacemaker, Model 5392 by Medtronic Cardiac Rhythm Disease Management, citing 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 conne….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1356-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-17 |
| Published | 2015-04-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Cardiac Rhythm Disease Management |
| Distribution | US |
Product
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 (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary cardiac pacing include, but are not limited to, the following: - Complete heart block - Sinus bradycardia - Sick sinus syndrome - Bradycardia with congestive heart failure - Atrial and/or ventricular arrhythmias - Cardiac arrest - Support, management, and evaluation of a patient before permanent pacemaker implantation - Support during permanent pacemaker replacement - Cardiac complications during invasive or surgical procedures - Support following cardiac surgery - Acute myocardial infarction complicated by heart block - Atrial tachyarrhythmias that require high-rate burst pacing for treatment
Reason
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.
Identifiers
| code_info | serial numbers equal or lower than DJH009999P |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1356-2015%22
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