Recall Z-2508-2020
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated June 4, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Azure S DR MRI, Model Number W3DR01
Codes / lots: serial numbers: RNJ200027H RNJ200025H RNJ200023H RNJ200022H RNJ200020H RNJ200018H RNJ200017H RNJ200015H RNJ200014H RNJ200011H RNJ200009H RNJ200008H RNJ200007H RNJ200006H RNJ200005H RNJ200004H RNJ200086H RNJ200085H RNJ200084H RNJ200083H RNJ200082H RNJ200081H RNJ200080H RNJ200078H RNJ200077H RNJ200076H RNJ200075H RNJ200074H RNJ200073H RNJ200072H RNJ200071H RNJ200070H RNJ200069H RNJ200068H RNJ200067H RNJ200066H RNJ200064H RNJ200063H RNJ200062H RNJ200061H RNJ200060H RNJ200059H RNJ200058H RNJ200057H RNJ200056H RNJ200055H RNJ200054H RNJ200052H RNJ200051H RNJ200050H RNJ200049H RNJ200048H RNJ200047H RNJ200046H RNJ200045H RNJ200043H RNJ200041H RNJ200040H RNJ200039H RNJ200038H RNJ200037H RNJ200036H RNJ200035H RNJ200034H RNJ200033H RNJ200032H RNJ200031H RNJ200030H RNJ200029H RNJ200028H RNJ200145H RNJ200144H RNJ200143H RNJ200142H RNJ200141H RNJ200140H RNJ200139H RNJ200138H RNJ200137H RNJ200135H RNJ200134H RNJ200133H RNJ200131H RNJ200129H RNJ200128H RNJ200127H RNJ200126H RNJ200125H RNJ200124H RNJ200123H RNJ200122H RNJ200121H RNJ200120H RNJ200119H RNJ200118H RNJ200117H RNJ200116H RNJ200115H RNJ200114H RNJ200113H RNJ200112H RNJ200111H RNJ200110H RNJ200107H RNJ200105H RNJ200104H RNJ200103H…
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-2508-2020
- Initiated
- June 4, 2020
- Posted by FDA
- July 10, 2020
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 49513 devices
- Distribution
- worldwide
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2505-2020 Class II | CareLink SmartSync Device Manager, Model Number 24970AThere is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | 06/04/2020Open, Classified |
| Z-2506-2020 Class II | Patient Connector, Model Number 24967There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | 06/04/2020Open, Classified |
| Z-2507-2020 Class II | Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | 06/04/2020Open, Classified |
| Z-2509-2020 Class II | Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | 06/04/2020Open, Classified |
| Z-2510-2020 Class II | Azure S SR MRI, Model Number W3SR01There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | 06/04/2020Open, Classified |
| Z-2511-2020 Class II | Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | 06/04/2020Open, Classified |
| Z-2512-2020 Class II | Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | 06/04/2020Open, Classified |
| Z-2513-2020 Class II | Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | 06/04/2020Open, Classified |