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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 86887

Description: Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 86887 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0928-2021
Event ID86887
Event DescriptionMedtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Product TypeDevices
DistributionDistribution to US states of GA, PA, NJ, and France
Quantity2 units
Recall ReasonUnder rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Device Classification20210203
Device Code InfoSerial Numbers: RSN600251S, RSN600656S
Center Classification Date20210126
Recall Initiation Date20201115
Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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