The Recall Desk
SevereFDA (Devices)·Z-2650-2016·Announced 2016-08-31

Medtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators

Medtronic is recalling 78 Viva Quadripolar Implantable Cardioverter Defibrillators because a circuit defect may cause rapid battery depletion. Seven confirmed failures have been reported.

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 reported complications including shortness of breath and pocket heating, which aligns with the rubric criteria for Severe (FDA Class II with hospitalization reports or significant injury).

Plain-English summary

Medtronic Inc. is recalling 78 Viva Quadripolar Implantable Cardioverter Defibrillators (ICDs) due to a potential defect in specific circuit components. The affected devices are the Viva XT CRT-D (models DTBA1D4, DTBA1D1) and Viva S CRT-D (models DTBB1D4, DTBB1D1). The recall covers 39 units in the United States and 39 units outside the US.

The recall is necessary because a low resistance path may develop within the circuit components, leading to rapid battery depletion. As of July 16, 2016, there have been seven confirmed failures. Reported complications associated with these failures include shortness of breath, pocket heating, low heart rate, and early device explant.

The devices were distributed worldwide, including in US states such as Arizona, California, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, and Texas, as well as in countries including Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, the Netherlands, Saudi Arabia, Spain, and the United Kingdom. Patients with these specific devices should contact their healthcare provider to discuss the recall and necessary follow-up actions.

The recalled product

Product
Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac
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: Viva XT CRT -D . Models: DTBA1D4
  • DTBA1D1. Serial Numbers: BLF203128H
  • BLF204746H
  • BLE202888H
  • BLE202889H
  • BLE202890H
  • BLE202901H
  • BLE202941H
  • BLE202947H
  • BLE202954H
  • BLE202958H
  • BLE202961H
  • BLE202962H
  • BLE202964H
  • BLE202981H
  • BLE202987H
  • BLE202989H
  • BLE202990H
  • BLE202991H
  • BLE203019H

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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