The Recall Desk
HighFDA (Devices)·Z-0585-2018·Announced 2018-02-28

Medtronic Recalls 951 Evera MRI ICDs Due to Therapy Prevention Risk

Medtronic is recalling 951 Evera MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy. Patients should contact their healthcare provider.

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 risk-of-harm product (ICD) where the failure to deliver therapy could be life-threatening, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Medtronic Inc. is recalling 951 Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, specifically the Evera MRI series. The affected models include the Evera MRI XT DR ICD DF1, Evera MRI XT DR ICD DF4, Evera MRI XT VR ICD DF4, Evera MRI S DR ICD DF1, and Evera MRI S DR ICD DF4. These devices are designed to automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.

The recall is being issued because of a possible prevention of high and low voltage therapy. This defect could interfere with the device's ability to deliver necessary electrical shocks or pacing to treat life-threatening heart rhythms. The devices were distributed nationwide in the United States.

Patients with these specific devices should contact their healthcare provider or the Medtronic recall hotline to discuss the risk and determine if a device replacement or other corrective action is necessary. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

Product
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Produ
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardioverter Defibrillator
Hazard
Affected units
951

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)

  • CWA200074H
  • CWA200576H
  • CWA200619H
  • CWA200837H
  • CWA200888H
  • CWA201175H
  • CWA201443H
  • CWA201760H
  • CWA201771H
  • CWA203003H
  • CWA203389H
  • CWA204111H
  • CWA204889H
  • CWA204890H
  • CWA205625H
  • CWA205694H
  • CWA205695H
  • CWA205703H
  • CWA206083H
  • CWA206177H

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

Related recalls

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

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Same hazard · therapy prevention

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