Recall Z-1123-2022 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
| Date | May 23, 2022 (initiated Mar 30, 2022) |
| Status | Open, Classified |
| Reason | The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system. |
| Root cause | Under Investigation by firm |
| Action | A customer letter, dated March 2022, was issued to the impacted consignee via mail. The consignee is instructed to ensure the patient programmer system is paired with the patient's INS. If the INS cannot communicate with the clinician programmer and/or patient programmer system, and it is not possible to make therapy adjustments, the consignee is to contact Medtronic Technical Services. The consignee is also asked to complete the customer confirmation form and submit to the recalling firm. Medtronic will be notifying consignees and actively retrieving any unused Vanta INS devices that con |
| Quantity | 1021 devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Italy, Sweden, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.