Recall Z-0132-2025 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Vanta Implantable Neurostimulator (INS), Model 977006
| Date | Oct 17, 2024 (initiated Aug 21, 2024) |
| Status | Open, Classified |
| Reason | Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements. |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 08/21/2024 via letter and email. The notice explained the issue, recommended mitigation, and requested the following: Required Actions: " Ensure that the Device Eligibility screen in the Model A71300 Clinician Programmer application is used during the trialing evaluation to review compatible INSs that will allow the same parameters used during the trial evaluation. " Ensure that the battery longevity tools in the Model A71200 Clinician Programmer application are used during each patient visit, to keep track o |
| Quantity | 11789 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.