FDA-Device2015-10-14Class II
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 conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.
Medtronic Inc. Cardiac Rhythm Disease Management
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.
Sold states
US nationwide distribution.
Affected count
777 cards
Manufactured in
8200 Coral Sea St NE, N/A, Saint Paul, MN, United States
Products
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 conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0022-2016Don't want to check this manually?
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