Medtronic CRT-D Implants Recalled for Rare Energy Output Failure Risk

Plain-English summary

Medtronic Inc. is recalling the CRT-D DTBA1D1 VIVA XT IS1/DF1 model implantable cardioverter defibrillators due to a rare potential for reduced or no energy output during high-voltage (HV) therapy, typically delivered at 0-12 joules. This defect is related to a specific type of feedthrough used in manufacturing these devices and could prevent the device from delivering therapy when needed.

This FDA Class I recall affects 1,473 units distributed nationwide and worldwide. The recalled devices are identified by specific lot serial numbers beginning with BLF (with either H or S suffixes) and GTIN codes 00643169720312 and 00763000059545.

Patients who have received one of these recalled CRT-D devices should contact their healthcare provider or Medtronic immediately to determine if their device is affected. Healthcare providers should verify patient device lot numbers and serial numbers against the recall list. Patients should not discontinue use of their device without consulting their physician, as the underlying condition for which the device was implanted remains a medical concern.

The recalled product

Product

CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators

Manufacturer

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

Category

Medical Device — Cardiac Implants / Defibrillators

Hazard

• device-malfunction
• reduced-energy-output

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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