Recall Z-2036-2023— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2023-06-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation. Reason: A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-06
- Firm location
- Minneapolis, MN, United States
Product description
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Reason for recall
A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.
Data sourced from openFDA. This site is unofficial and independent of the FDA.