Implantable Defibrillators May Fail During High-Voltage Cardiac Therapy
Medtronic implantable defibrillators may fail to deliver energy during high-voltage cardiac therapy due to a defective glassed feedthrough component. The recall affects 2,968 units distributed nationwide and 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 indicates reasonable probability of serious adverse health consequences. Device failure during critical cardiac defibrillation therapy poses life-threatening risk. Although no incidents are explicitly reported, the potential for harm is serious.
Plain-English summary
Medtronic Inc. is recalling CRTD COBALT HF MRI IS1 DF4 implantable cardioverter defibrillators (Model DTPB2D4) due to a rare potential for reduced or no energy output during high-voltage therapy. The devices use a specific glassed feedthrough that may fail, particularly during defibrillation therapy delivered at 0-12 joules, which is critical for treating dangerous heart rhythms.
The recall affects 2,968 units distributed in the United States and worldwide. Both implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are included. Currently available units may contain the affected feedthrough.
Patients and healthcare providers with these devices should review the affected lot serial numbers provided by the FDA. The feedthrough defect could prevent the device from delivering necessary high-voltage therapy, potentially leaving patients without defibrillation capability during a cardiac emergency.
The recalled product
- Product
- CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
- Affected units
- 2,968
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 00763000178215
- Lot Serial Numbers: RTO600161S
- RTO600247S
- RTO601140S
- RTO601641S
- RTO602045S
- RTO602335S
- RTO602270S
- RTO600314S
- RTO601040S
- RTO601383S
- RTO600175S
- RTO600229S
- RTO600417S
- RTO600458S
- RTO600507S
- RTO600650S
- RTO601039S
- RTO602060S
- RTO603798S
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 · electrical component failure
See all →- HighDRX Revolution Mobile X-Ray System Electrical Component Failure Recall
FDA (Devices) · 2023-12-13
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