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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D)."
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…
- 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
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See all →- SevereMedtronic Recalls Claria MRI CRT-Ds Due to Therapy Prevention Risk
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