Reported Jun 4, 2014 · Terminated
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI).…
Medtronic Inc. Cardiac Rhythm Disease Management
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc. Cardiac Rhythm Disease Management · 8200 Coral Sea St NE · Saint Paul, MN · 55112-4391
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
5348. | Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic |
5433A | or 5433V) or a surgical cable (Medtronic |
5832 | or 5832S). |
- Lot codes and dates
- serial numbers
2,716 of 2,716 codes
PEP001001KPEP001001PPEP001002KPEP001002PPEP001003KPEP001003PPEP001004KPEP001004PPEP001005KPEP001005PPEP001006KPEP001006PPEP001007KPEP001007PPEP001008KPEP001008PPEP001009KPEP001009PPEP001010KPEP001010PPEP001011KPEP001011PPEP001012KPEP001012PPEP001013KPEP001013PPEP001014KPEP001014PPEP001015KPEP001015PPEP001016KPEP001016PPEP001017KPEP001017PPEP001018KPEP001018PPEP001019KPEP001019PPEP001020KPEP001020PPEP001021KPEP001021PPEP001022KPEP001022PPEP001023KPEP001023PPEP001024KPEP001024PPEP001025KPEP001025PPEP001026KPEP001026PPEP001027KPEP001027PPEP001028KPEP001028PPEP001029KPEP001029PPEP001030KPEP001030P
- serial numbers
- Amount recalled
- 16,337 (8,989 US; 7,348 OUS)
Where it was sold
Why it was recalled
Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.
This product could cause temporary or reversible health problems — stop using it.
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