The LivaNova VNS Therapy System recall: Software Issue
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external…
Why was The LivaNova VNS Therapy System recalled?
Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existing thresholds of 600 - 5300 Ohms defined in labeling and as present in the programming software.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers Less Than 100000
- Product
- The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external…
- Recalling firm
- LivaNova USA Inc
- Quantity
- 9282
- Distribution
- US: PA, WV, KY, NY, MD, VA, DC, NC, GA, SC, NJ, DE, MA, OH, RI, CT, ME, NH, VT, IL, WI, IN, MO, MI, MN, SD, ND, NE,KS, IA, TX, OK, TN, MS, AL, FL, LA, ID, MT, WA, OR, UT, AK, AZ, AZ , CO, WY, NM, CA, HI, AR. Foreign (OUS): Austria, Switzerland, Germany, Denmark, Spain, Finland, United Kingdom, Italy, Netherlands, Norway, Portugal, Sweden
- Recall date
- November 13, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)