The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-0587-2018·Announced 2018-02-28

Medtronic Recalls Evera ICDs Due to Possible Therapy Prevention

Medtronic is recalling 951 Evera ICDs and CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5) due to the potential for serious adverse health consequences or death.

Plain-English summary

Medtronic Inc. is recalling 951 Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices from the Evera family. The recall involves specific models including the Evera S DR ICD DF1, Evera S VR ICD DF1, and Evera XT DR ICD DF1, among others. These devices are distributed nationwide in the United States.

The recall is issued because the devices may fail to deliver high or low voltage therapy. These devices are designed to automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some models also provide resynchronization therapy, including sequential biventricular pacing.

Patients with these specific devices should contact their healthcare provider to determine if they are affected and to discuss appropriate next steps. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recalled product

Product
Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e.…
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)

  • BWG201119H
  • BWG201913H
  • BWG204028H
  • BWG204300H
  • BWG205740H
  • BWG205936H
  • BWG206156H
  • BWG206745H
  • BWG206747H
  • BWG206882H
  • BWG206883H
  • BWG206884H
  • BWG206885H
  • BWG207389H
  • BWG207390H)
  • b. Product No. DVBC3D1: UDI 00643169929852 (Serial No. BWM204635H)
  • 00643169017900 (Serial No. BWM204192H) (EXPANSION: Serial No. BWM201169H
  • BWM202293H
  • BWM203256H
  • BWM203852H

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 →

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