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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- electrical-component-failure
- defibrillation-therapy-failure
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.
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