Product Safety Recalls

Product Recall Tracker

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 87769

Description: Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 87769 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1650-2021
Event ID87769
Event DescriptionCobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Product TypeDevices
DistributionUS Nationwide distribution in the state of North Carolina.
Quantity2 units
Recall ReasonThe device may contain a manufacturing defect of a missing resistance spot weld (RSW).
Device Classification20210526
Device Code InfoProduct Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S
Center Classification Date20210520
Recall Initiation Date20210407
Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.