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Recall Observatory FDA recall evidence

Device product

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.

Z-0022-2016

September 15, 2015

Class II

Product summary

Firm
Medtronic Inc. Cardiac Rhythm Disease Management
Event
Event 72245
Status
Terminated
Classification
Class II
Quantity
777 cards
Official record key
device-enforcement:Z-0022-2016

Official wording

Reason: 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.

Code information: no codes on the cards

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.