The Recall Desk
HighFDA (Devices)·Z-1305-2021·Announced 2021-04-07

Medtronic Recalls Implantable Cardioverter Defibrillators Due to Shortened Replacement Time

Medtronic is recalling specific Evera and Visia ICD models because a small percentage may experience a shortened Recommended Replacement Time to End of Service interval.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (ICD) where a defect could lead to device failure, but the source text does not report any injuries, deaths, or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Medtronic Inc. is recalling approximately 290,086 units of implantable cardioverter defibrillators (ICDs) from the Evera and Visia families. The affected models include the Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR, Evera MRI S VR, Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD. These devices are used to automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.

The recall is being issued because a small percentage of implanted cardiac devices from a well-defined subset may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation. This means the devices may reach the end of their service life sooner than originally anticipated.

The affected devices were distributed worldwide, including the United States (nationwide), Puerto Rico, and numerous countries across Europe, Asia, Africa, and the Americas. Patients with these specific ICD models should contact their healthcare provider to discuss the recall and determine if any action is required regarding their device's replacement timeline.

The recalled product

Product
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Impla
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardioverter Defibrillator
Hazard
Affected units
290,086

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)

  • BWC230184H
  • BWC230891H
  • BWC228489H
  • BWC232037H
  • BWC230770H
  • BWC231219H
  • BWC231215H
  • BWC231190H
  • BWC231202H
  • BWC231199H
  • BWC231780H
  • BWC231556H
  • BWC230255H
  • BWC230772H
  • BWC230906H
  • BWC231500H
  • BWC231572H
  • BWC231618H
  • BWC231655H
  • BWC231937H

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 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 (CRHF)

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Same hazard · device failure

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