Implantable Defibrillators Risk Loss of Therapy from Feedthrough Defect
Medtronic recalls certain CRT-D VIVA QUAD XT GOLD implantable defibrillators due to a rare risk of reduced or no electrical output during therapy. Affected devices contain a specific glassed feedthrough component.
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 affecting implantable cardiac defibrillators with potential for loss of critical therapy delivery. Although no incidents have been reported, FDA Class I classification reflects serious potential for harm and must not score below 4 per the rubric.
Plain-English summary
Medtronic Inc. is recalling certain CRT-D VIVA QUAD XT GOLD CTD implantable cardioverter defibrillators (Model DTBA2QQG, Lot BLG626306S) manufactured with a specific glassed feedthrough component. These devices were distributed nationwide and worldwide.
The defect creates a rare potential for reduced or no electrical output during high voltage defibrillation therapy, typically at 0-12 joule levels. Loss of therapy delivery could leave dangerous heart rhythms untreated, creating serious health risk.
Patients with these devices should discuss the recall with their healthcare provider to determine if monitoring, replacement, or other interventions may be appropriate.
The recalled product
- Product
- CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; 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 00643169518223
- Lot Serial Numbers: BLG626306S
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.
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