Reported Jul 5, 2023 · Ongoing
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
- Lot codes and dates
- GTIN 00763000411923
- Serial/Lot Numbers
2,657 of 2,657 codes
NMS504094HNMS504258HNMS504861HNMS503154HNMS503612HNMS503371HNMS503748HNMS504643HNMS504701HNMS504404HNMS504802HNMS504344HNMS504771HNMS504778HNMS504650HNMS501450HNMS504544HNMS501538HNMS503203HNMS503064HNMS501373HNMS503404HNMS504791HNMS504792HNMS501978HNMS502528HNMS501313HNMS501469HNMS503521HNMS502644HNMS504254HNMS502974HNMS504955HNMS503078HNMS503079HNMS504657HNMS501285HNMS501484HNMS504381HNMS501266HNMS502517HNMS502681HNMS504772HNMS501163HNMS504243HNMS502056HNMS504636HNMS505065HNMS503237HNMS501226HNMS502346HNMS502407HNMS503392HNMS503395HNMS504259HNMS504337HNMS504402HNMS504606HNMS504610HNMS505010H
- Lot Serial Numbers
NMS502362HNMS502806HNMS502812HNMS502824HNMS505229HNMS506124HNMS506126HNMS506130HNMS505235HNMS505238HNMS502817HNMS503600HNMS505231HNMS502357HNMS503743HNMS503751HNMS503836HNMS504002HNMS506271HNMS503767HNMS505574HNMS505858HNMS505859HNMS506261HNMS502584HNMS504947HNMS503776HNMS503781HNMS505882HNMS502369HNMS503622HNMS503628HNMS505350HNMS502366HNMS502399HNMS505567HNMS505569HNMS505916HNMS505920HNMS505937HNMS506087HNMS506090HNMS503830HNMS503834HNMS505526HNMS505279HNMS505636HNMS505881HNMS505896HNMS505053HNMS505742HNMS505222HNMS505227HNMS5052
- Amount recalled
- 3791 devices
Why it was recalled
A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.
This product could cause temporary or reversible health problems — stop using it.
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