Home / Recalls / Medical Devices
Medtronic Inc. Cardiac Rhythm Disease Management recalls Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies
Recalled October 14, 2015 · FDA recall Z-0022-2016 · 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. · FDA Class II
Units
777 cards
Sold at
US nationwide distribution.
Description
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.
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.
Manufacturer(s)
Medtronic Inc. Cardiac Rhythm Disease Management
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →