Recall Z-2507-2020
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 XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
Codes / lots: 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 RNB200136H RNB200137H RNB200138H RNB200139H RNB200140H RNB200141H RNB200143H RNB200144H RNB200145H RNB200146H RNB200147H RNB200148H RNB200149H RNB200150H RNB200151H RNB200153H RNB200154H RNB200155H RNB200156H RNB200158H RNB200159H RNB200160H RNB200161H RNB200163H RNB200164H…
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-2507-2020
- Initiated
- June 4, 2020
- Posted by FDA
- July 10, 2020
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 266252 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-2508-2020 Class II | Azure S DR MRI, Model Number W3DR01There 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 |