Z-1574-2022Class II

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

Name: Z-1574-2022 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 communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1574-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-26
Posted: 2022-08-25
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 communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator.
FDA root cause: Under Investigation by firm
Action: On about 07/26/2022, Medtronic notified consignees via letter titled "URGENT: MEDICAL DEVICE CORRECTION" sent through courier service. The notification instructed consignees to hold off implanting more than one Vanta INS in a patient until software update is available and while not recommended, if implanting a patient with two (2) Vanta INSs, ensure the INSs are implanted on opposite sides of the body as noted in the Information for Prescribers labeling, and ensure each is configured with the CP App before implanting in a patient. Consignees were asked to complete and return the customer confirmation form provided an contact Medtronic Technical Services at 1-800-707-0933 if troubleshooting does not resolve any issues encountered.
Quantity in commerce: 4386 downloaded software applications
Distribution: Worldwide distribution - US 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, WY 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-1574-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1574-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25

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)