Recall record at a glance
| Official record | Z-1305-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Ongoing |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Report date | Apr 7, 2021 |
| Recall initiation date | Feb 3, 2021 |
| Quantity | 290086 units |
| Location | Mounds View, MN, United States |
Official product description
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. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
Why the product was recalled
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
Distribution information
Worldwide Distribution: US (nationwide) Including Puerto Rico and countries of: Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Montenegro, Morocco, Namibia, Nepal, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam Virgin Islands (British), Yemen and Zimbabwe.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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