—#195423

Product

Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: Model A71200; Software Version 2.0.2455

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 return the customer confirmation form provided.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: 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 countries of Austria, Belgium, Canada, Canary Islands, Cayman Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.

Timeline

Recall initiated: 2022-07-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195423. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.