Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac paci...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1356-2015.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1356-2015.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Medtronic Inc. Cardiac Rhythm Disease Management or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1356-2015.
Medtronic Inc. Cardiac Rhythm Disease Management
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Medtronic Inc. Cardiac Rhythm Disease Management Recall FAQ
Medtronic Inc. Cardiac Rhythm Disease Management is the subject of a medical implants safety report: Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac paci.... The notice was published on March 17, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 6,040 units are potentially affected.