LivaNova VNS Therapy Programming System Recalled for Unintended Warning Messages
LivaNova is recalling 243 VNS Therapy Programming Systems because they may display unintended warning messages. The devices were distributed to 16 U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The specific defect is an unintended warning message, which is a software/display issue rather than a direct physical hazard like shock or failure to deliver therapy, placing it in the Moderate category.
Plain-English summary
LivaNova USA Inc is recalling 243 units of the VNS Therapy Programming System, Model 3000, version 1.0.2.2. The recall was initiated because the devices may display unintended warning messages on generators programmed with this specific programmer model.
The affected devices were distributed domestically to Arizona, California, Georgia, Iowa, Illinois, Indiana, Missouri, Montana, North Carolina, New York, Pennsylvania, South Dakota, Tennessee, Texas, Washington, and Wisconsin. The recall number is Z-2572-2018.
Healthcare providers and patients should check their device serial numbers against the list provided in the official recall notice. If a device is affected, LivaNova will provide instructions for the necessary corrective actions.
The recalled product
- Product
- VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
- Manufacturer
- LivaNova USA Inc
- Affected units
- 243
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part Number 10-0011-0500
- FKR57F2 (01054250257503991117091821FKR57F29910 0011 0500)
- FCR77F2 (01054250257503991117091821FCR77F29910 0011 0500)
- CJR77F2 (01054250257503991117091821CJR77F29910 0011 0500)
- BNT77F2 (01054250257503991117091821BNT77F29910 0011 0500)
- BNS77F2 (01054250257503991117091821BNS77F29910 0011 0500)
- 7XR77F2 (010542502575039911170918217XR77F29910 0011 0500)
- 7XP57F2 (010542502575039911170918217XP57F29910 0011 0500)
- 79R77F2 (0105425025750399111709182179R77F29910 0011 0500)
- 90S77F2 (0105425025750399111709182190S77F29910 0011 0500)
- 97Q57F2 (0105425025750399111709182197Q57F29910 0011 0500)
- 6NT77F2 (010542502575039911170918216NT77F29910 0011 0500)
- 9GP57F2 (010542502575039911170918219GP57F29910 0011 0500)
- 6KQ57F2 (010542502575039911170918216KQ57F29910 0011 0500)
- B7Q57F2 (01054250257503991117091821B7Q57F29910 0011 0500)
- 57P57F2 (0105425025750399111709182157P57F29910 0011 0500)
- 55T77F2 (0105425025750399111709182155T77F29910 0011 0500)
- J6R57F2 (01054250257503991117091821J6R57F29910 0011 0500)
- HWR77F2 (01054250257503991117091821HWR77F29910 0011 0500)
- 1G7G1F2 (010542502575039911170918211G7G1F29910 0011 0500)
Distribution
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