Reported Jul 4, 2018 · Terminated
Single Chamber Temporary External Pacemaker, Model 53401
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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 and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Single Chamber Temporary External Pacemaker, Model 53401
- Lot codes and dates
1,821 of 1,821 codes
Serial Numbers MDB01005EPMDB01006EPMDB01007EPMDB01008EPMDB01009EPMDB01010EPMDB01011EPMDB01012EPMDB01013EPMDB01014EPMDB01015EPMDB01016EPMDB01017EPMDB01018EPMDB01019EPMDB01036EPMDB01037EPMDB01038EPMDB01039EPMDB01040EPMDB01041EPMDB01042EPMDB01043EPMDB01044EPMDB01045EPMDB01046EPMDB01047EPMDB01048EPMDB01049EPMDB01050EPMDB01051EPMDB01052EPMDB01053EPMDB01054EPMDB01055EPMDB01056EPMDB01057EPMDB01058EPMDB01060EPMDB01061EPMDB01062EPMDB01063EPMDB01064EPMDB01065EPMDB01066EPMDB01067EPMDB01068EPMDB01069EPMDB01070EPMDB01071EPMDB01072EPMDB01073EPMDB01074EPMDB01075EPMDB01076EPMDB01077EPMDB01078EPMDB01079EPMDB01080EPMDB01081EP
- Amount recalled
- 1,108 devices
Where it was sold
Why it was recalled
A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected Power on Reset (POR).
This product could cause temporary or reversible health problems — stop using it.
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