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.
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: "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"
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.…
- 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
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
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Similar recalls
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