Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure
Medtronic's ICD COBALT defibrillators may fail to deliver critical therapy due to a manufacturing defect in a power delivery component. Patients should contact their physician to determine if affected.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I designation indicates a reasonable probability of serious adverse health consequences or death. The defect could prevent a critical cardiac device from delivering life-saving therapy when needed.
Plain-English summary
Medtronic Inc. has recalled 1,941 ICD COBALT DR MRI IS1 DF1 model defibrillators (Model DDPB3D1) due to a manufacturing defect in the device's power delivery component. The devices may produce reduced or no energy output during high voltage therapy, potentially preventing them from delivering needed treatment.
The defect affects units manufactured with a specific glassed feedthrough component. The recall applies to currently available implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with this component. Affected devices have been distributed nationwide and worldwide.
Patients with these devices should contact their physician or Medtronic immediately to determine if their unit is affected and discuss appropriate next steps, which may include device replacement or reprogramming.
The recalled product
- Product
- ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
- Affected units
- 1,941
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 00763000178376
- Lot Serial Numbers: RSN600341S
- RSN601060S
- RSN601316S
- RSN601817S
- RSN602193S
- RSN600668S
- RSN600669S
- RSN600670S
- RSN600672S
- RSN601804S
- RSN601808S
- RSN601810S
- RSN602514S
- RSN601050S
- RSN601241S
- RSN602551S
- RSN600820S
- RSN603061S
- RSN601870S
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 · reduced energy output
See all →- SevereImplantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators may deliver reduced or no energy during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable cardioverter defibrillators may output reduced or no energy during therapy
FDA (Devices) · 2023-06-28
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