Recall Z-1571-2022 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
| Date | Jul 26, 2022 |
| Status | Open, Classified |
| Reason | Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be unable to perform programming of the Vanta Implantable Neurostimulator (INS) Model 977006. |
| Root cause | Under Investigation by firm |
| Action | On about 07/26/2022, Medtronic notified consignees via mail courier service with a letter titled "URGENT: MEDICAL DEVICE CORRECTION." The letter instructed consignees to perform an initial interrogation of the Vanta INS and tap start usage, tap implant device workflow, click start, and on the next screen exit the session, and to initiate a second interrogation and if there is no "Unexpected Device Error Code 1502" code the INS maybe used. If the INS cannot be interrogated, contact Medtronic Technical Services at 1-800-707-0933. Additionally, consignees were instructed to complete and |
| Quantity | 2,920 downloaded software applications |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AK, 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. The countrie |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.