Recall Z-2511-2020
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
Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
Codes / lots: a) W1TR01, serial numbers: RNO200006H RNO200023H RNO200029H RNO200036H RNO200038H RNO200041H RNO200044H RNO200048H RNO200050H RNO200051H RNO200064H RNO200070H RNO200086H RNO200088H RNO200096H RNO200105H RNO200109H RNO200110H RNO200136H RNO200140H RNO200012H RNO200013H RNO200025H RNO200030H RNO200031H RNO200034H RNO200035H RNO200037H RNO200043H RNO200046H RNO200047H RNO200054H RNO200055H RNO200056H RNO200058H RNO200060H RNO200061H RNO200065H RNO200067H RNO200068H RNO200069H RNO200071H RNO200072H RNO200074H RNO200075H RNO200076H RNO200078H RNO200079H RNO200081H RNO200082H RNO200084H RNO200085H RNO200087H RNO200091H RNO200093H RNO200098H RNO200099H RNO200101H RNO200111H RNO200112H RNO200115H RNO200116H RNO200118H RNO200121H RNO200122H RNO200125H RNO200127H RNO200128H RNO200129H RNO200131H RNO200132H RNO200133H RNO200134H RNO200137H RNO200138H RNO200141H RNO200143H RNO200144H RNO200145H RNO200027H RNO200100H RNO200106H RNO200151H RNO200155H RNO200162H RNO200103H RNO200165H RNO200166H RNO200167H RNO200168H RNO200169H RNO200171H RNO200173H RNO200174H RNO200175H RNO200178H RNO200179H RNO200180H RNO200181H RNO200182H RNO200183H RNO200184H RNO200185H RNO200186H RNO200187H RNO200188H…
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-2511-2020
- Initiated
- June 4, 2020
- Posted by FDA
- July 10, 2020
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 37360 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-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 |