Implantable Defibrillators May Fail to Deliver Energy During Therapy
Medtronic implantable cardioverter defibrillators (CRT-Ds) may fail to deliver adequate energy during high-voltage treatment due to a manufacturing defect in the feedthrough component, affecting 373 units.
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: FDA Class I recall with no reported illnesses or injuries. While the hazard is theoretical, the FDA Class I classification requires a minimum severity score of 4 per the rubric.
Plain-English summary
This is an FDA Class I recall of Medtronic CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US implantable cardioverter defibrillators (ICDs and CRT-Ds). The devices may fail to deliver adequate or no electrical energy during high-voltage therapy (typically 0-12 joules) due to a defect in a specific glassed feedthrough component.
A total of 373 units with specific lot serial numbers are affected. The devices are distributed nationwide in the United States and worldwide.
Patients with these devices should contact their healthcare provider to determine if their device is among those affected by this recall. A healthcare provider can assess whether the device needs replacement or additional monitoring and discuss appropriate next steps based on the patient's medical condition.
The recalled product
- Product
- CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators
- Affected units
- 373
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 00643169720190
- Lot Serial Numbers: BLD212440H
- BLD212962H
- BLD212366H
- BLD212449H
- BLD212473H
- BLD212554H
- BLD212653H
- BLD212675H
- BLD212791H
- BLD212822H
- BLD212902H
- BLD212926H
- BLD213003H
- BLD213009H
- BLD212351H
- BLD212699H
- BLD212811H
- BLD212406H
- BLD212432H
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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