Flowonix Prometra II Pump
Flowonix
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 SeriousA pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
💡 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.
12/23/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousA pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
💡 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.
12/23/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousA pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
💡 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.
12/23/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousFlowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to permit safe exposure to an MRI without removing drug from the reservoir.
💡 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.
5/21/2017 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousPhysician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as 'reuse the same drug solution extracted from the pump prior to the MRI procedure', creating a possible risk of infection
💡 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.
5/25/2021 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
💡 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.
3/20/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
💡 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.
3/20/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
💡 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.
3/20/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
💡 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.
3/20/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousA pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
💡 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.
12/23/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousA pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
💡 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.
12/23/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
💡 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.
3/20/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousFlowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to permit safe exposure to an MRI without removing drug from the reservoir.
💡 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.
5/21/2017 · View on FDA.gov
FDA Recall Alert
Class II — ModerateFlowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to permit safe exposure to an MRI without removing drug from the reservoir.
💡 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.
5/21/2017 · 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.
Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.
Category
Infusion Pumps
Body Region
Abdomen
MRI Conditions
MRI conditional. CRITICAL: Drug reservoir must be COMPLETELY EMPTIED prior to MRI.
Clinical Warnings
CRITICAL WARNING: Reservoir MUST be completely emptied before MRI to prevent potentially lethal medication discharge.
Post-MRI Notes
Refill reservoir after MRI. Verify pump function.
Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.