Implantable Defibrillators Recalled for Potential Therapy Failure During High-Voltage Treatment
Medtronic is recalling specific Implantable Cardioverter Defibrillator (ICD) models due to a rare potential for reduced or no energy output during high-voltage therapy. The issue is related to a specific manufacturing defect in the device feedthrough.
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 medical device recall, which indicates reasonable probability of serious adverse health consequences. Although no illnesses or injuries are currently reported, the defect affects a critical life-saving device and the potential failure to deliver therapy could result in serious harm.
Plain-English summary
Medtronic Inc. is recalling the ICD EVERA XT DR GOLD CTD (Model DDBB1D4G), an implantable cardioverter defibrillator. This device is surgically implanted to detect and treat abnormal heart rhythms by delivering electrical therapy.
A rare potential exists for reduced or no energy output during high-voltage therapy (typically 0-12 joules) in devices manufactured with a specific glassed feedthrough. This manufacturing defect could prevent the device from delivering necessary therapy when needed.
The affected devices are distributed nationwide and worldwide. Patients with this device model should contact their healthcare provider for guidance on this recall.
The recalled product
- Product
- ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators
- Affected units
- 1
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 (2)
- GTIN 00643169518216
- Lot Serial Numbers: BWB232002H
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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