Recall Z-2512-2020
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
Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
Codes / lots: a) W1TR02, serial numbers: RNQ200008H RNQ200032H RNQ200035H RNQ200043H RNQ200045H RNQ200049H RNQ200051H RNQ200052H RNQ200057H RNQ200059H RNQ200061H RNQ200074H RNQ200076H RNQ200080H RNQ200096H RNQ200100H RNQ200102H RNQ200107H RNQ200109H RNQ200110H RNQ200111H RNQ200130H RNQ200132H RNQ200133H RNQ200003H RNQ200005H RNQ200006H RNQ200007H RNQ200010H RNQ200011H RNQ200017H RNQ200018H RNQ200020H RNQ200022H RNQ200025H RNQ200028H RNQ200029H RNQ200031H RNQ200033H RNQ200034H RNQ200036H RNQ200039H RNQ200040H RNQ200050H RNQ200054H RNQ200056H RNQ200060H RNQ200062H RNQ200064H RNQ200065H RNQ200067H RNQ200071H RNQ200072H RNQ200075H RNQ200077H RNQ200078H RNQ200081H RNQ200085H RNQ200088H RNQ200091H RNQ200093H RNQ200098H RNQ200103H RNQ200105H RNQ200108H RNQ200115H RNQ200116H RNQ200119H RNQ200120H RNQ200123H RNQ200124H RNQ200125H RNQ200126H RNQ200128H RNQ200131H RNQ200135H RNQ200137H RNQ200141H RNQ200145H RNQ200146H RNQ200147H RNQ200152H RNQ200154H RNQ200157H RNQ200158H RNQ200162H RNQ200167H RNQ200168H RNQ200169H RNQ200171H RNQ200174H RNQ200012H RNQ200134H RNQ200136H RNQ200139H RNQ200140H RNQ200183H RNQ200149H RNQ200150H RNQ200159H RNQ200160H RNQ200163H RNQ200176H RNQ200178H RNQ200179H RNQ200180H…
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-2512-2020
- Initiated
- June 4, 2020
- Posted by FDA
- July 10, 2020
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 17750 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-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-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 |