Implantable defibrillators may fail to deliver high-voltage therapy during treatment
Certain Medtronic ICD and CRT-D devices with a specific feedthrough may fail to deliver energy during high-voltage therapy. This rare defect affects 9,325 units worldwide and could compromise cardiac protection.
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: This is an FDA Class I recall involving life-critical implanted defibrillator devices. While no illnesses or deaths are reported in the source, the potential failure mode—reduced or absent high-voltage therapy output—represents a serious risk to patients dependent on these devices for cardiac protection. FDA Class I classification mandates a minimum severity score of 4.
Plain-English summary
Medtronic has recalled approximately 9,325 units of its ICD COBALT XT VR MRI DF4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough component. Affected devices may produce reduced or no electrical energy output during high-voltage (HV) therapy delivery, which typically operates at 0-12 joules.
The defect poses a serious risk because it could prevent the device from delivering the high-voltage therapy needed to treat dangerous abnormal heart rhythms. While the potential for energy loss is rare, the failure mode—inability to deliver therapy—could compromise the device's critical function of protecting the patient from life-threatening cardiac events.
These devices have been distributed throughout the United States and worldwide. The affected units are identified by specific lot serial numbers that have been provided to healthcare facilities and cardiologists.
Patients with an affected ICD or CRT-D should contact their cardiologist or the implanting facility to determine whether their device is among those recalled. Verification can be done using the device's serial number. Patients should continue with regular scheduled device follow-up visits and seek immediate emergency medical care if they experience symptoms of heart rhythm problems.
The recalled product
- Product
- ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
- Affected units
- 9,325
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 00763000178468. Lot Serial numbers: RSD605765S
- RSD605767S
- RSD607880S
- RSD607881S
- RSD607886S
- RSD607890S
- RSD603551S
- RSD603552S
- RSD603553S
- RSD603554S
- RSD603555S
- RSD600536S
- RSD601541S
- RSD602283S
- RSD602524S
- RSD602542S
- RSD602924S
- RSD603303S
- RSD603396S
- RSD607136S
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
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- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
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- 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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