Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
Reported: June 1, 2022 Initiated: March 30, 2022 #Z-1123-2022
Product Description
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
Reason for Recall
The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 1021 devices
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of 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, NE, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Italy, Sweden, Netherlands, Belgium, United Kingdom, Japan, Finland, Portugal, Spain, Canary Islands, Denmark, Germany, Switzerland, Ireland, Croatia, Norway.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.. Recalled by Medtronic Neuromodulation. Units affected: 1021 devices.
Why was this product recalled? ▼
The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 1, 2022. Severity: Moderate. Recall number: Z-1123-2022.
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