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U.S. Department of Health and Human Services

Class 2 Device Recall Vanta Clinician Programmer Application

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  Class 2 Device Recall Vanta Clinician Programmer Application see related information
Date Initiated by Firm July 26, 2022
Create Date August 24, 2022
Recall Status1 Open3, Classified
Recall Number Z-1571-2022
Recall Event ID 90686
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Code Information Model A71200; Software Version 2.0.2455
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Michelle Claypool
763-526-9452
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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