FDA Medical Device Recalls (openFDA)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
- Recall number
- Z-0928-2021
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Product
- Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
- Status
- Terminated
- Initiated
- 2020-11-15
- Posted
- not on file
- Terminated
- 2025-12-23
- Reason
- Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 2 units
- Distribution
- Distribution to US states of GA, PA, NJ, and France
- Lot, serial or model codes
- Serial Numbers: RSN600251S, RSN600656S
- 510(k) numbers
- not on file
- PMA numbers
- ["P010031"]
- Product code
- NIK
- Firm FEI
- 2182208
- Firm city
- Mounds View
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28