Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy

Plain-English summary

Medtronic Inc. is recalling specific implantable cardioverter defibrillators (CRT-D), Model DTBB1D4 VIVA S IS1/DF4 US. The devices may deliver reduced or no electrical energy during high-voltage therapy (typically 0-12 joules) due to a manufacturing defect in the feedthrough component. This is a Class I recall issued by the FDA.

The recall affects 182 units distributed nationwide and worldwide. The affected devices are identified by specific lot serial numbers listed in the FDA recall documentation. Patients with affected devices and their healthcare providers should consult the FDA recall notice.

The specific manufacturing defect involves a glassed feedthrough component that can impair the device's ability to deliver therapy. While the risk is described as rare, the potential failure of a lifesaving therapy device during treatment represents a serious patient safety concern.

The recalled product

Product

CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators

Manufacturer

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

Category

Medical Device — Implantable Cardioverter Defibrillator

Hazard

• energy-output-failure
• therapy-delivery-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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