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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-1571-2022
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
not on file
Terminated
not on file
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 return the customer confirmation form provided.
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 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

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