Implantable Defibrillators May Fail to Deliver High Voltage Therapy
Certain Medtronic implantable cardioverter defibrillators may deliver reduced or no energy during high voltage therapy due to a defective feedthrough. This defect could prevent the device from properly treating life-threatening heart rhythms.
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: The FDA classified this as a Class I recall, indicating serious adverse health consequences are reasonably probable. Although no patient illnesses have been reported in the source, the potential for complete therapy failure in implanted cardiac devices that treat life-threatening arrhythmias carries inherent serious risk.
Plain-English summary
Medtronic is recalling certain ICD COBALT XT DR MRI IS1 DF1 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a potential defect in the device.
The recalled devices contain a specific glassed feedthrough that has a rare potential for reduced or no energy output during high voltage therapy, typically in the 0-12 joule range. This malfunction could prevent the device from delivering the necessary electrical therapy to treat life-threatening arrhythmias.
Approximately 2,748 units of the recalled device have been distributed in the United States and worldwide. Patients who have received this specific model should contact their healthcare provider to determine if they have an affected device.
Patients with affected devices should consult with their physician or cardiologist to discuss whether their device needs to be replaced or reprogrammed. Do not discontinue using the device without medical guidance, as the risk of harm from device discontinuation may outweigh the risk from the potential defect.
The recalled product
- Product
- ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
- Affected units
- 2,748
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 00763000178338
- Lot Serial Numbers: RSL602442S
- RSL601336S
- RSL600186S
- RSL602060S
- RSL601499S
- RSL601501S
- RSL602893S
- RSL602901S
- RSL602941S
- RSL602955S
- RSL602420S
- RSL602899S
- RSL601490S
- RSL602690S
- RSL600167S
- RSL600499S
- RSL600561S
- RSL600563S
- RSL600564S
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
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