FDA Device recall Z-2506-2020
Patient Connector, Model Number 24967
- FDA Device
- Class II
- ongoing
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of Patient Connector, Model Number 24967 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-2506-2020 |
| 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
Patient Connector, Model Number 24967
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: RFA001342A RFA001412A RFA001748A RFA001760A RFA001802A RFA001845A RFA001868A RFA001885A RFA002…serial numbers: RFA001342A RFA001412A RFA001748A RFA001760A RFA001802A RFA001845A RFA001868A RFA001885A RFA002011A RFA002039A RFA002152A RFA003642A RFA003644A RFA003652A RFA003658A RFA003669A RFA003671A RFA003673A RFA003677A RFA003684A RFA003690A RFA003691A RFA003692A RFA003703A RFA003704A RFA003705A RFA004075A RFA004079A RFA004082A RFA004208A RFA004218A RFA004232A RFA004277A RFA004386A RFA004390A RFA004391A RFA004681A RFA004706A RFA005006A RFA005009A RFA005011A RFA005023A RFA005025A RFA005028A RFA005029A RFA005049A RFA005079A RFA005081A RFA005093A RFA005095A RFA005097A RFA005103A RFA005105A RFA005125A RFA005249A RFA005989A RFA006832A RFA008087A RFA008119A RFA008908A RFA009323A RFA010721A RFA010722A RFA010895A RFA011167A RFA011196A RFA011348A RFA011359A RFA011456A RFA011493A RFA011519A RFA011725A RFA011764A RFA011770A RFA011774A RFA011780A RFA011795A RFA011796A RFA011797A RFA011824A RFA011827A RFA011840A |
|---|
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-2506-2020%22
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