Recall Z-1306-2021 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava fa
| 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 | 238393 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.