FDASeptember 15, 2015device
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR condi...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.
What to do
FDA enforcement status: Terminated
Brands named
medtronic inc cardiac rhythm disease managementmedtronicmedtronic inc
Recall history
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