FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
- Recall number
- Z-1574-2022
- Recalling firm
- Medtronic Neuromodulation
- Product
- Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
- Status
- Open, Classified
- Initiated
- 2022-07-26
- Posted
- 2022-08-25
- Terminated
- not on file
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- Model A71200; Software Version 2.0.2455
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LGW
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28