Recall Z-1305-2021 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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
| Date | Mar 27, 2021 (initiated Feb 3, 2021) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Device Design |
| Action | The firm, Medtronic, issued an "Urgent Medical Device Correction" letter dated February 2021 to its consignees in the United States via UPS 2-day delivery. The letter described the product, problem and actions to be taken. Medtronic recommends the customers do the following: Continue normal follow-up per local clinical protocol. o Recognize that patients who require significant pacing support and high voltage therapy have the lowest risk for this issue - See Appendix A for additional details. o Where possible, take advantage of the CareLink" home monitoring system and the wireless low batte |
| Quantity | 290086 units |
| Distribution | 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, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.