Medtronic Temporary Pacemaker Recalled for Battery Connection Failure
Medtronic is recalling 6,040 Model 5392 temporary pacemakers because specific AA batteries may fail to connect, potentially stopping pacing therapy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device that could abruptly stop delivering life-sustaining pacing therapy, posing a significant risk of serious injury.
Plain-English summary
Medtronic Inc. Cardiac Rhythm Disease Management is recalling 6,040 units of the Dual Chamber Temporary External Pacemaker, Model 5392. The recall affects devices with serial numbers equal to or lower than DJH009999P. These devices were distributed worldwide, including in all US states and territories, and numerous international countries.
The recall is due to a possible performance issue when the device is used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA battery may not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the external pacemaker from powering on or cause it to abruptly lose primary battery power, potentially stopping the delivery of pacing therapy.
This product is intended for use in a clinical environment by trained personnel for temporary single or dual chamber pacing. Because the device must be used in an environment where the patient is monitored continuously, the risk of abrupt power loss is a significant safety concern. Users should contact Medtronic for instructions on how to proceed.
The recalled product
- 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
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Hazard
- Affected units
- 6,040
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- serial numbers equal or lower than DJH009999P
Distribution
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