Delta Shunt Assembly
Medtronic Neurosurgery
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 SeriousPotential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
💡 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.
1/10/2021 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousNeonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
💡 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.
12/15/2020 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousNeonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
💡 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.
12/15/2020 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousNeonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
💡 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.
12/15/2020 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousMedtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
💡 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.
11/17/2013 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousMedtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
💡 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.
11/17/2013 · View on FDA.gov
FDA Recall Alert
Class II — ModerateMedtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
💡 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.
11/17/2013 · 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
CSF Shunts & Valves
View Manufacturer MR Safety Documentation
Official Medtronic Neurosurgery guidelines
MRI Conditions
MRI conditional up to 3.0T
Clinical Warnings
Programmable shunts may require reprogramming after MRI. Non-programmable shunts generally considered MRI safe or conditional up to 3T.
Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.