Implantable Defibrillators May Deliver Reduced or No Energy During Therapy

Plain-English summary

This recall involves Medtronic Inc.'s Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Model DVBB1D1 (EVERA XT IS1/DF1 US). The devices are being recalled due to a rare potential for reduced or no energy output during high voltage therapy.

The defect is caused by a specific (glassed) feedthrough used in the device. During high voltage therapy (typically 0-12J), this feedthrough may rarely cause the device to produce reduced energy or no energy at all, potentially preventing the device from delivering therapy as intended.

The recall affects 16 units that were distributed nationwide and worldwide. The affected devices carry the following lot serial numbers: BWI218211H, BWI218218H, BWI218226H, BWI218228H, BWI218206H, BWI218224H, BWI218210H, BWI218222H, BWI218217H, BWI218214H, BWI218216H, BWI218208H, BWI218207H, BWI218221H, BWI218212H, and BWI218220H.

Patients implanted with these devices should contact their healthcare provider or Medtronic to verify whether their device is affected. Healthcare providers should review this recall notice and the FDA recall database for additional information and guidance.

The recalled product

Product

ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Category

Medical Device — Implantable Cardioverter Defibrillator

Hazard

• reduced-energy-output
• therapy-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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