Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Lot Codes / Batch Numbers
Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S
Products Sold
Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization T due to The device may contain a manufacturing defect of a missing resistance spot weld (RSW).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
Recommended Action
Per FDA guidance
During the week of 07-Apr-2021, Medtronic initiated retrieval activities for 1 device (1 US/0 OUS) for a consignee in possession of a potentially affected, non-implanted device according to Medtronic records. The Consignee was verbally notified that the consigned units was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The representative was made aware that a formal notification to customer regarding these immediate actions would follow once the engineering evaluations were complete. In the United States, beginning 20-Apr-2021, a formal Urgent Medical Device Recall notification was delivered via a field sales representative, to the consignee who was part of the retrieval activities initiated the week of 07-Apr-2021. This letter will also be mailed via UPS 2-day delivery. The Consignee will be asked to confirm receipt of the letter and that they have acknowledge the actions taken for the non-implanted, affected product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026