Recall Z-2505-2020
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
CareLink SmartSync Device Manager, Model Number 24970A
Codes / lots: serial numbers: SPM001078A SPM001117A SPM001120A SPM001139A SPM001140A SPM001141A SPM001174A SPM001231A SPM001250A SPM001251A SPM001252A SPM001253A SPM001262A SPM001265A SPM001266A SPM001270A SPM001281A SPM001284A SPM001285A SPM001363A SPM001377A SPM001394A SPM001396A SPM001398A SPM001403A SPM001404A SPM001407A SPM001419A SPM001424A SPM001425A SPM001441A SPM001445A SPM001449A SPM001456A SPM001463A SPM001465A SPM001474A SPM001477A SPM001478A SPM001482A SPM001484A SPM001486A SPM001491A SPM001519A SPM001544A SPM001545A SPM001552A SPM001554A SPM001555A SPM001556A SPM001557A SPM001559A SPM001560A SPM001561A SPM001562A SPM001571A SPM001581A SPM001584A SPM001587A SPM001588A SPM001633A SPM001659A SPM001660A SPM001661A SPM001662A SPM001663A SPM001664A SPM001665A SPM001666A SPM001667A SPM001668A SPM001669A SPM001670A SPM001671A SPM001672A SPM001673A SPM001674A SPM001675A SPM001676A SPM001677A SPM001683A SPM001684A SPM001685A SPM001686A SPM001704A SPM001705A SPM001706A SPM001707A SPM001709A SPM001710A SPM001711A SPM001712A SPM001713A SPM001714A SPM001715A SPM001716A SPM001719A SPM001720A SPM001721A SPM001723A SPM001732A SPM001733A SPM001734A SPM001735A SPM001738A SPM001739A SPM001745A…
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-2505-2020
- Initiated
- June 4, 2020
- Posted by FDA
- July 10, 2020
- Quantity
- 2773 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-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 |
| 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 |