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)
Hazard
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
What You Should Do
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.
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
- Brand
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- UPC
- Serial Numbers: RTK602501S, RTK602506S
Units Affected
2 units