Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Lot Codes / Batch Numbers
Serial Numbers: RTK602501S, RTK602506S
Products Sold
Serial Numbers: RTK602501S, RTK602506S
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardio due to Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of fu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Recommended Action
Per FDA guidance
During the week of 15-Nov-2020, Medtronic initiated retrieval activities for 6 devices (5 US/1 OUS) for consignees in possession of potentially affected, non-implanted devices according to Medtronic records. Consignees were either verbally directed by Medtronic Field Representatives to quarantine product, or in the case of consigned units, the product was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The firm will follow with a letter to be disseminated on 12/04/2020 to the risk managers.
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 noticeDistribution
As reported by FDA
GA, NJ, PA
Page updated: Jan 10, 2026