Z-1571-2022Class II

Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta...

Name: Z-1571-2022 Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta...
Creator: Medtronic Neuromodulation
Published: 2022-07-26
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2022-07-26 / Open, Classified

FDA source

Medtronic Neuromodulation began a recall of Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy on 2022-07-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1571-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-26
Posted: 2022-08-24
Recalling firm: Medtronic Neuromodulation
Product: Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: 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.
FDA 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 return the customer confirmation form provided.
Quantity in commerce: 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 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.
Product codes and lots: Model A71200; Software Version 2.0.2455

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1571-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1571-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-24

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)