FDA Device recall Z-2507-2020
Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
- FDA Device
- Class II
- ongoing
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 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-2507-2020 |
| 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 XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
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 | a) W1DR01, serial numbers: RNB200043H RNB200044H RNB200045H RNB200046H RNB200047H RNB200048H RNB200049H RNB2000…a) W1DR01, serial numbers: RNB200043H RNB200044H RNB200045H RNB200046H RNB200047H RNB200048H RNB200049H RNB200050H RNB200051H RNB200052H RNB200053H RNB200054H RNB200055H RNB200056H RNB200057H RNB200058H RNB200059H RNB200060H RNB200064H RNB200065H RNB200066H RNB200067H RNB200068H RNB200069H RNB200070H RNB200071H RNB200072H RNB200073H RNB200074H RNB200075H RNB200076H RNB200079H RNB200080H RNB200081H RNB200082H RNB200083H RNB200084H RNB200085H RNB200086H RNB200087H RNB200088H RNB200089H RNB200091H RNB200094H RNB200095H RNB200096H RNB200098H RNB200099H RNB200100H RNB200101H RNB200102H RNB200103H RNB200105H RNB200106H RNB200107H RNB200108H RNB200109H RNB200111H RNB200112H RNB200113H RNB200114H RNB200115H RNB200116H RNB200117H RNB200118H RNB200119H RNB200120H RNB200121H RNB200122H RNB200123H RNB200124H RNB200125H RNB200126H RNB200127H RNB200128H RNB200129H RNB200130H RNB200131H RNB200132H RNB200133H RNB200135H |
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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-2507-2020%22
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