Medtronic ICD COBALT XT Recalled for Potential Energy Output Failure
Medtronic has recalled certain implantable defibrillators (ICDs) due to a potential for reduced or no-energy output during therapy. Affected devices may fail to deliver required treatment for dangerous 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: This is an FDA Class I recall of life-sustaining medical devices that could fail to deliver critical therapy. Although the source describes only a 'rare potential' for harm with no reported adverse events or injuries, the FDA's Class I classification for implantable defibrillators establishes a minimum severity of Severe.
Plain-English summary
Medtronic Inc. has recalled approximately 2,000 units of ICD COBALT XT VR MRI implantable cardioverter defibrillators (Model DVPA2D1) due to a potential for reduced or no-energy output during high-voltage therapy. The issue stems from a specific glassed feedthrough component in the devices.
The affected defibrillators are designed to detect and treat abnormal heart rhythms. If the device's energy delivery system malfunctions, these life-sustaining devices may fail to deliver required high-voltage therapy during critical cardiac events.
The recalled devices were distributed in the United States and worldwide. Medtronic has documented specific lot serial numbers affected by this recall.
Patients with one of these recalled devices should consult with their healthcare provider or contact Medtronic to assess their individual risk and discuss any necessary monitoring or management options.
The recalled product
- Product
- ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators
- Affected units
- 2,000
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 00763000178451
- Lot Serial Numbers: RSC601940S
- RSC601072S
- RSC601241S
- RSC600327S
- RSC601396S
- RSC602028S
- RSC602030S
- RSC602031S
- RSC602036S
- RSC600018S
- RSC602529S
- RSC602530S
- RSC602531S
- RSC602532S
- RSC600347S
- RSC600391S
- RSC600419S
- RSC601490S
- RSC602703S
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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