Recall Z-2513-2020
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
Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
Codes / lots: a) W1TR03, serial numbers: RNS200027H RNS200037H RNS200043H RNS200044H RNS200045H RNS200052H RNS200059H RNS200063H RNS200068H RNS200076H RNS200077H RNS200079H RNS200081H RNS200088H RNS200089H RNS200090H RNS200094H RNS200098H RNS200100H RNS200005H RNS200007H RNS200016H RNS200020H RNS200022H RNS200025H RNS200026H RNS200028H RNS200030H RNS200032H RNS200033H RNS200034H RNS200038H RNS200042H RNS200050H RNS200051H RNS200054H RNS200060H RNS200061H RNS200064H RNS200065H RNS200067H RNS200071H RNS200072H RNS200074H RNS200080H RNS200082H RNS200084H RNS200085H RNS200086H RNS200087H RNS200091H RNS200093H RNS200099H RNS200101H RNS200053H RNS200104H RNS200109H RNS200111H RNS200116H RNS200118H RNS200019H RNS200040H RNS200092H RNS200035H RNS200102H RNS200103H RNS200105H RNS200107H RNS200108H RNS200110H RNS200113H RNS200115H RNS200117H RNS200119H RNS200120H RNS200121H RNS200122H RNS200123H RNS200125H RNS200126H RNS200127H RNS200048H RNS200128H RNS200130H RNS200140H RNS200124H RNS200129H RNS200143H RNS200144H RNS200131H RNS200138H RNS200132H RNS200136H RNS200137H RNS200133H RNS200134H RNS200135H RNS200148H RNS200149H RNS200150H RNS200151H RNS200154H RNS200155H RNS200156H RNS200158H RNS200159H…
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-2513-2020
- Initiated
- June 4, 2020
- Posted by FDA
- July 10, 2020
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 16667 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-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 |