LivaNova AspireSR VNS

LivaNova

Not determinedIndexed from FDA records

MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.

Don't schedule an MRI based on this page alone — your MRI team verifies every device.

What this means for you

MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
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For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

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FDA Recall Alert

Class I — Most Serious

Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

12/11/2024 · View on FDA.gov

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FDA Recall Alert

Class I — Most Serious

Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

1/2/2025 · View on FDA.gov

⚠️

FDA Recall Alert

Class I — Most Serious

Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

1/2/2025 · View on FDA.gov

⚠️

FDA Recall Alert

Class I — Most Serious

Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

12/11/2024 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

9/27/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

12/1/2021 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

11/11/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

11/15/2018 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

11/15/2018 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

8/21/2019 · View on FDA.gov

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FDA Recall Alert

Class I — Most Serious

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 this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

11/15/2018 · View on FDA.gov

⚠️

FDA Recall Alert

Class I — Most Serious

This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

11/15/2018 · View on FDA.gov

⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.

Regulatory Info

No 510(k) clearance data available for this device.

⚠️6 Active Recalls

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Neuro

Body Region

Vagus Nerve Stimulators

MRI Scan Parameters

Max Field Strength3.0T

MRI Conditions

MRI conditional 1.5T head only (transmit/receive head coil).

Clinical Warnings

MR Conditional at 1.5T and 3.0T. Mandatory programming: device must be programmed by a healthcare professional to Stimulation OFF and Sensing (AutoStim) OFF before the scan, and reverted afterward.

Post-MRI Notes

System diagnostics REQUIRED after MRI. Verify lead impedance and generator function. Reprogram therapy settings from 0.0 mA back to prescribed output.

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Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.