FDA Device recall Z-2510-2020
Azure S SR MRI, Model Number W3SR01
- FDA Device
- Class II
- ongoing
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of Azure S SR MRI, Model Number W3SR01 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2510-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-06-04 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
Product
Azure S SR MRI, Model Number W3SR01
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 presence of a magnet.
Identifiers
| code_info | serial numbers: RNI200028H RNI200029H RNI200031H RNI200033H RNI200034H RNI200037H RNI200038H RNI200039H RNI200…serial numbers: RNI200028H RNI200029H RNI200031H RNI200033H RNI200034H RNI200037H RNI200038H RNI200039H RNI200041H RNI200042H RNI200043H RNI200044H RNI200045H RNI200046H RNI200048H RNI200050H RNI200051H RNI200053H RNI200054H RNI200055H RNI200057H RNI200058H RNI200059H RNI200061H RNI200063H RNI200064H RNI200065H RNI200066H RNI200067H RNI200069H RNI200071H RNI200072H RNI200076H RNI200077H RNI200078H RNI200079H RNI200080H RNI200081H RNI200082H RNI200083H RNI200084H RNI200085H RNI200086H RNI200087H RNI200088H RNI200089H RNI200090H RNI200091H RNI200094H RNI200095H RNI200096H RNI200097H RNI200098H RNI200099H RNI200100H RNI200101H RNI200102H RNI200103H RNI200104H RNI200105H RNI200106H RNI200107H RNI200108H RNI200109H RNI200111H RNI200112H RNI200113H RNI200115H RNI200118H RNI200119H RNI200121H RNI200122H RNI200123H RNI200124H RNI200125H RNI200126H RNI200127H RNI200128H RNI200130H RNI200132H RNI200134H RNI200135H |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2510-2020%22
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