LivaNova recalls VNS Therapy System generators with serial numbers less than 100,000 due to higher impedance readings during diagnostics, potentially causing incorrect settings. Affected users should contact for guidance.
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.
LivaNova is recalling VNS Therapy System generators with serial numbers below 100,000 because they report higher impedance values than expected during diagnostic tests. This could lead to incorrect stimulation settings, though serious injury risks are not described in the recall.
The affected generator measures impedance differently during diagnostic tests, causing reported values to be higher than normal. This shift could lead to incorrect stimulation settings if the system misinterprets the readings.
Patients with a VNS Therapy System implant using the affected generator model (serial numbers less than 100,000) are most at risk. Medical professionals who program the system may also need to check settings.
Check the serial number on the generator. Affected units have serial numbers less than 100,000. The generator was approved for sale in the U.S. starting October 3, 2017.
Look for the serial number on the generator's housing; affected units have numbers below 100,000.
The affected generator reports higher impedance values during diagnostic tests than expected, which could lead to incorrect stimulation settings.
The recall only applies to generators with serial numbers less than 100,000. If your serial number is higher, no action is needed.
The recall does not mention any risk of serious injury. The hazard is related to potential incorrect settings but not immediate danger.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-0346-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-0346-2020 from LivaNova. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
