Medtronic Dual Chamber Temporary External Pacemaker — Class II medical device recall Z-1356-2015
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2015-04-08, distributed nationwide. Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commer
| Recall number | Z-1356-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2015-03-17 |
| Classified | 2015-03-31 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2015-10-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BO, BR, BS, CA, CH, CO, CY, CZ, DE, DK, DO, EG, ES, FR, GB, GR, GY, HK, HN, HR, HU, ID, IE, IL, IN, IS, IT, JO, KR, KW, LB, LK, LU, MA, MY, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, QA, RS, SA, SE, SG, SI, SK, TH, TN, TT, UY, VE, VN, ZA |
| Quantity | 6,040 devices |
| Model numbers | 5392 |
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 for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.