Medtronic Cobalt DR MRI SureScan Defibrillators Recalled for Potential Loss of Function
Medtronic is recalling two specific MRI SureScan defibrillators because a component failure could cause the device to lose function.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a failure could lead to loss of function, but the source text does not report any specific injuries, hospitalizations, or deaths, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Inc. is recalling two units of the Cobalt DR MRI SureScan DDPB3D1, an MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry. The recall affects specific serial numbers RSN600251S and RSN600656S.
The recall is being issued because, under rare circumstances, a component in the device may be susceptible to a failure mechanism. This failure could impact overall device performance, including the potential loss of function.
The affected units were distributed to the US states of Georgia, Pennsylvania, and New Jersey, as well as France. Patients with these specific devices should contact their healthcare provider or Medtronic for further instructions regarding the recall.
The recalled product
- Product
- Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial Numbers: RSN600251S
- RSN600656S
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
Similar recalls
- HighMedtronic COBALT DR MRI ICD Recalled for Manufacturing Defect
FDA (Devices) · 2024-07-03
- HighMedtronic Recalls Two Defective Implantable Cardioverter Defibrillators
FDA (Devices) · 2021-05-26
- HighMedtronic COBALT DR MRI SureScan ICD Recalled Due to Manufacturing Weld Crack
FDA (Devices) · 2024-07-03
- HighImplantable defibrillator recalled for manufacturing defect causing device failure risk
FDA (Devices) · 2024-07-03
- HighMedtronic COBALT VR MRI SureScan implantable defibrillators recalled for manufacturing defect
FDA (Devices) · 2024-07-03
- HighMedtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03