Medtronic ICD COBALT DR Potential Reduced Energy Output During Therapy
Medtronic's ICD COBALT DR MRI defibrillators may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The rare potential affects 11,645 units distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification establishes a minimum severity of 4 per the rubric rules. Although no illnesses or injuries have been reported in the source, the potential for complete failure of critical life-saving therapy delivery in an implantable cardiac device during cardiac emergencies represents a serious health risk.
Plain-English summary
Medtronic Inc. is recalling ICD COBALT DR MRI IS1 DF4 (Model DDPB3D4) implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators manufactured with a specific glassed feedthrough component. The affected product includes 11,645 units with multiple lot serial numbers.
There is a rare potential for reduced or no-energy output during high voltage therapy delivery, typically in the 0-12J range. This defect could prevent the device from delivering necessary defibrillation therapy during cardiac emergencies.
The devices were distributed nationwide in the United States and worldwide. Patients with affected devices should contact their healthcare provider or Medtronic immediately to verify if their device serial number is affected and discuss appropriate management options.
The FDA classified this as a Class I recall. Patients should not discontinue using their devices without consulting their cardiologist, as the risk of operating without the device may outweigh the recall risk. Immediate consultation with a healthcare provider is strongly recommended.
The recalled product
- Product
- ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators
- Affected units
- 11,645
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 (20)
- GTIN 00763000178390
- Lot Serial Numbers: RSO600207S
- RSO600934S
- RSO602587S
- RSO602860S
- RSO603892S
- RSO600679S
- RSO612257S
- RSO602636S
- RSO604992S
- RSO609567S
- RSO609647S
- RSO609795S
- RSO609900S
- RSO610931S
- RSO607136S
- RSO609278S
- RSO601095S
- RSO601096S
- RSO601098S
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 120 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 120 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
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- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Same hazard · therapy delivery failure
See all →- HighPhysio-Control Defibrillators May Lack Required Performance Inspection
FDA (Devices) · 2026-05-13
- SevereMedtronic Implantable Cardiac Defibrillators Risk Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators With Defective Feedthrough May Fail to Deliver Therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- CriticalImplantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
FDA (Devices) · 2023-06-28
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