Z-1356-2015Class II

Medtronic Dual Chamber Temporary External Pacemaker, Model 5392

Name: Z-1356-2015 Medtronic Dual Chamber Temporary External Pacemaker, Model 5392
Creator: Medtronic Inc. Cardiac Rhythm Disease Management
Published: 2015-03-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-03-17 / Terminated / root cause: design

FDA source

Medtronic Inc. Cardiac Rhythm Disease Management began a recall of Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary... on 2015-03-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1356-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-17
Posted: 2015-03-31
Terminated: 2015-10-08
Recalling firm: Medtronic, Inc.
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
Product code: DTE Pulse-Generator, Pacemaker, External
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.
Root cause tag: design
FDA root cause: Device Design
Action: Medtronic sent an "Urgent Medical Device Correction" letter dated March 2015 to affected customers. The letter was addressed to Risk Manager or Health Care Professional. The letter described the Issue and Customer Actions to be taken. The letter requested customers to complete and return the Customer Confirmation Certificate. For questions contact your Medtronic representative, for technical questions call Instrument Technical Service at 800-638-1991.
Quantity in commerce: 6040 devices
Distribution: Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MI, MM, MS, MO, MT, NE NV,N, NM, NY, NC, ND, OH,OK, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, PR, VI and the countries of:Australia, Austria, Bahamas, Belgium, Bolivia ,Botswana, Brazil ,Brunei, Darussalam, Bulgaria, Burkina Faso, Canada, Colombia, Croatia, Cyprus, Czech Republic, Denmark,, Dominican Republic, Egypt, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Luxembourg, Macedonia, Malaysia, Mauritius, Morocco, Mozambique, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Papua, New Guinea, Peru, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, St. Pierre and Miquelon,Sweden, Switzerland, Tanzania, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, and Yemen. .
Product codes and lots: serial numbers equal or lower than DJH009999P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1356-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1356-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-31

Product code DTE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)