The Recall Desk
SevereFDA (Devices)·Z-2651-2016·Announced 2016-08-31

Medtronic Evera ICDs Recalled for Rapid Battery Depletion Risk

Medtronic is recalling 78 Evera ICDs and Viva CRT-Ds due to a circuit defect causing rapid battery depletion. Seven confirmed failures have resulted in complications like shortness of breath.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves confirmed device failures with reported complications such as shortness of breath and low heart rate, meeting the criteria for Severe severity.

Plain-English summary

Medtronic Inc. is recalling 78 Evera Implantable Cardioverter Defibrillators (ICDs) and Viva CRT-Ds. The affected devices include specific models of the Evera XT DR, Evera S DR, and Evera XT VR ICDs, as well as Viva CRT-Ds. These devices were manufactured with a specific subset of circuit components that may develop a low resistance path, leading to rapid battery depletion.

The recall affects 39 units in the United States and 39 units outside the US. Distribution in the US includes Arizona, California, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, and Texas. International distribution includes Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, the Netherlands, Saudi Arabia, Spain, and the United Kingdom.

As of July 16, 2016, there have been seven confirmed failures, representing 9% of the affected units. Reported complications associated with these failures include shortness of breath, pocket heating, low heart rate, and early device explant. Patients with these devices should contact their healthcare provider for evaluation and potential replacement.

The recalled product

Product
Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardiov
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure
Category
Medical Device — Implantable Cardioverter Defibrillator
Hazard

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)

  • Product Name: Evera XT DR lCD. Models: DDBB1D4
  • DDBB1D1
  • DDBB2D4
  • DDBB2D1. Serial Numbers: BWC202738H
  • BWC202754H
  • BWB202998H
  • BWB203157H
  • BWB203167H
  • BWB203173H
  • BWB203186H
  • BWE601558S
  • BWE601571S
  • BWE601578S
  • BWE601579S
  • BWE601581S
  • BWE601589S
  • BWE601591S
  • BWE601594S
  • BWE601600S
  • BWE601605S

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure 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 2 products in this recall →

Related recalls

Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure

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Same hazard · battery depletion

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