Recall Z-2509-2020 ยท NVZ Pulse Generator, Permanent, Implantable
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
| Date | Jul 10, 2020 (initiated Jun 4, 2020) |
| Status | Open, Classified |
| Reason | There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or p |
| Root cause | Software design |
| Action | The firm initiated their medical device correction on 06/04/2020 by letter. The letter explained the problem and informed the consignee of the available software update (version 3.2.01) along with download instructions. |
| Quantity | 31736 devices |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.