Implantable Defibrillators Recalled for Rare Risk of Energy Output Failure
Medtronic implantable defibrillators may deliver reduced or no energy during therapy due to a rare electrical defect. Approximately 1,914 units with a specific feedthrough component are affected and 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 requires a minimum severity score of 4. Although no deaths or serious injuries have been reported and the hazard is described as a 'rare potential,' the Class I designation for a life-critical cardiac device with potential therapy failure warrants a Severe classification.
Plain-English summary
Medtronic Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), including the CRTD COBALT XT HF MRI IS1 DF4 model. Approximately 1,914 devices have been distributed in the United States and worldwide.
Devices manufactured with a specific electrical feedthrough component have a rare potential for reduced or no energy output during high voltage therapy, typically at 0-12 joules. This defect may prevent the devices from delivering the intended electrical therapy to manage heart rhythm.
Patients who have received these implanted devices are potentially affected. The FDA has classified this as a Class I recall, which indicates the reasonable probability that use of a defective product could cause serious adverse health consequences or death.
Patients with these devices should consult their healthcare provider to determine whether their device may be affected. Healthcare providers can verify device serial numbers against the recall lot numbers identified by Medtronic and the FDA.
The recalled product
- Product
- CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators
- Affected units
- 1,914
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 00763000178130
- Lot Serial Numbers: RTG605297S
- RTG605299S
- RTG600588S
- RTG601635S
- RTG601691S
- RTG601840S
- RTG601857S
- RTG602986S
- RTG601966S
- RTG601364S
- RTG601621S
- RTG600270S
- RTG600554S
- RTG601405S
- RTG601699S
- RTG601977S
- RTG605270S
- RTG600137S
- RTG600138S
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
FDA (Devices) · 2023-06-28
- 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 · energy output failure
See all →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic CRT-D and ICD Defibrillators Recalled for Potential Therapy Output Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators risk energy output failure during high voltage therapy
FDA (Devices) · 2023-06-28
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