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

FDA device recall Z-1574-2022 · posted 2022-08-25 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LGW

Quantity affected

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,

Date initiated

2022-07-26

Date posted

2022-08-25

Location

Minneapolis, MN