FDA Device recall Z-2513-2020
Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
- FDA Device
- Class II
- ongoing
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06 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-2513-2020 |
| 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
Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
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) W1TR03, serial numbers: RNS200027H RNS200037H RNS200043H RNS200044H RNS200045H RNS200052H RNS200059H RNS20006…a) W1TR03, serial numbers: RNS200027H RNS200037H RNS200043H RNS200044H RNS200045H RNS200052H RNS200059H RNS200063H RNS200068H RNS200076H RNS200077H RNS200079H RNS200081H RNS200088H RNS200089H RNS200090H RNS200094H RNS200098H RNS200100H RNS200005H RNS200007H RNS200016H RNS200020H RNS200022H RNS200025H RNS200026H RNS200028H RNS200030H RNS200032H RNS200033H RNS200034H RNS200038H RNS200042H RNS200050H RNS200051H RNS200054H RNS200060H RNS200061H RNS200064H RNS200065H RNS200067H RNS200071H RNS200072H RNS200074H RNS200080H RNS200082H RNS200084H RNS200085H RNS200086H RNS200087H RNS200091H RNS200093H RNS200099H RNS200101H RNS200053H RNS200104H RNS200109H RNS200111H RNS200116H RNS200118H RNS200019H RNS200040H RNS200092H RNS200035H RNS200102H RNS200103H RNS200105H RNS200107H RNS200108H RNS200110H RNS200113H RNS200115H RNS200117H RNS200119H RNS200120H RNS200121H RNS200122H RNS200123H RNS200125H RNS200126H RNS200127H R |
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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-2513-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.