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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- device-malfunction
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.
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