Boston Scientific Vercise Cartesia Directional Lead
Boston Scientific
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:
- Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
- Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
- 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:
- Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
- Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
- 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.
For information only — your MRI team makes the final decision before any scan. They check every patient, every time.
FDA Recall Alert
Class I — Most SeriousThe performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.
💡 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.
8/28/2013 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.
💡 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.
8/28/2013 · View on FDA.gov
FDA Recall Alert
Class II — ModerateProduct manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
💡 What this means for you
This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.
10/20/2019 · View on FDA.gov
FDA Recall Alert
Class II — ModerateProduct manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
💡 What this means for you
This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.
10/20/2019 · View on FDA.gov
FDA Recall Alert
Class II — ModerateProduct manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
💡 What this means for you
This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.
10/20/2019 · View on FDA.gov
FDA Recall Alert
Class II — ModerateProduct manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
💡 What this means for you
This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.
10/20/2019 · View on FDA.gov
FDA Recall Alert
Class II — ModerateProduct manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
💡 What this means for you
This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.
10/20/2019 · View on FDA.gov
FDA Recall Alert
Class II — ModerateProduct manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
💡 What this means for you
This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.
10/20/2019 · View on FDA.gov
FDA Recall Alert
Class II — ModerateA review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.
💡 What this means for you
This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.
6/18/2014 · 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.
Category
Neuro
Body Region
Deep Brain Stimulators
View Manufacturer MR Safety Documentation
Official Boston Scientific guidelines
MRI Conditions
MRI conditional with compatible IPG.
Clinical Warnings
MRI conditional with STRICT protocols. Physician must enable MRI mode before scan. Specific SAR limits, coil types, and body regions apply.
Post-MRI Notes
Interrogate device after MRI to verify settings and function.
Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.