LivaNova recalls VNS Therapy SENTIVA Generator Model 1000 units that were sterilized with an extra cycle, which may not meet quality standards. Affected units have specific model labels and serial numbers.
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
LivaNova is recalling VNS Therapy SENTIVA Generator Model 1000 devices that were sterilized one additional cycle, which doesn't meet their quality specifications. This could affect device safety and reliability.
The generators were sterilized one additional cycle beyond the firm's quality specifications, which could lead to potential safety issues. However, the hazard is not described as causing immediate injury or serious harm in normal use.
Patients using the VNS Therapy SENTIVA Generator Model 1000 with specific model labels and serial numbers are most at risk. The recall affects a subset of units that were sterilized incorrectly.
Check for model labels with 'Model 1000' and serial numbers starting with 204460, 183960, 194980, 204700, 206720, or 213290. The units were sold with specific labeling codes like 26-0009-6800 or 26-0009-9600.
Look for model labels with 'Model 1000' and serial numbers starting with 204460, 183960, 194980, 204700, 206720, or 213290.
LivaNova identified a subset of generators that were sterilized one additional cycle, which does not meet their quality specifications.
Check for model labels with 'Model 1000' and serial numbers starting with 204460, 183960, 194980, 204700, 206720, or 213290.
The recall does not specify a remedy, so contact LivaNova directly for further instructions.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-1118-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-1118-2020 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.
