Recall Z-2510-2020
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 SR MRI, Model Number W3SR01
Codes / lots: serial numbers: RNI200028H RNI200029H RNI200031H RNI200033H RNI200034H RNI200037H RNI200038H RNI200039H RNI200041H RNI200042H RNI200043H RNI200044H RNI200045H RNI200046H RNI200048H RNI200050H RNI200051H RNI200053H RNI200054H RNI200055H RNI200057H RNI200058H RNI200059H RNI200061H RNI200063H RNI200064H RNI200065H RNI200066H RNI200067H RNI200069H RNI200071H RNI200072H RNI200076H RNI200077H RNI200078H RNI200079H RNI200080H RNI200081H RNI200082H RNI200083H RNI200084H RNI200085H RNI200086H RNI200087H RNI200088H RNI200089H RNI200090H RNI200091H RNI200094H RNI200095H RNI200096H RNI200097H RNI200098H RNI200099H RNI200100H RNI200101H RNI200102H RNI200103H RNI200104H RNI200105H RNI200106H RNI200107H RNI200108H RNI200109H RNI200111H RNI200112H RNI200113H RNI200115H RNI200118H RNI200119H RNI200121H RNI200122H RNI200123H RNI200124H RNI200125H RNI200126H RNI200127H RNI200128H RNI200130H RNI200132H RNI200134H RNI200135H RNI200137H RNI200138H RNI200139H RNI200140H RNI200141H RNI200142H RNI200144H RNI200146H RNI200147H RNI200148H RNI200149H RNI200150H RNI200151H RNI200152H RNI200155H RNI200156H RNI200157H RNI200158H RNI200159H RNI200160H RNI200161H RNI200162H RNI200163H RNI200164H RNI200166H…
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-2510-2020
- Initiated
- June 4, 2020
- Posted by FDA
- July 10, 2020
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 11953 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-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-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 |