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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 90429

Description: Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 90429 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1480-2022
Event ID90429
Event DescriptionCobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Product TypeDevices
DistributionUS Nationwide distribution in the states of Indiana and CA.
Quantity3 units
Recall ReasonManufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Device Classification20220803
Device Code InfoGTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
Center Classification Date20220728
Recall Initiation Date20201105
Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Initial Notification Telephone
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