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Flowonix Medical, Inc.

Last updated May 23, 2026

What Flowonix Medical, Inc. makes

Flowonix Medical, Inc. manufactures programmable intrathecal infusion pumps, including implantable and clinician-controlled models, alongside accessories like spinal infusion/drainage catheters and subcutaneous tunnelling tools. Their product line also includes single-use surgical kits for general procedures and physician-configuration devices for pump programming. The company produces both standalone programmer tools and integrated systems for managing patient therapy, such as catheter revision kits and therapy controllers.

All devices produced by Flowonix Medical, Inc. fall under FDA Class III classification, requiring premarket approval (PMA) or de novo clearance. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory compliance. The company operates within the United States, adhering to domestic medical device regulations.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 013518517

Catalogue (14)

Device	Model / Reference	Registries	Class	Status
Prometra Tunneler	11826	FDA UDI	Class III	Active
Prometra Physician Configuration Device	12861	FDA UDI	Class III	Active
Prometra Catheter Access Kit	11824	FDA UDI	Class III	Active
Prometra Clinician Programmer Print Tool	12840	FDA UDI	Class III	Active
Prometra Intrathecal Catheter	11823	FDA UDI	Class III	Active
Prometra Programmer	11828	FDA UDI	Class III	Active
Prometra Programmable Pump	11827	FDA UDI	Class III	Active
Prometra Clinical Programmer	13828	FDA UDI	Class III	Active
Prometra Patient Therapy Controller	12860	FDA UDI	Class III	Active
Prometra II Pump	13827	FDA UDI	Class III	Active
Prometra Programmable Pump	16827	FDA UDI	Class III	Active
Prometra Catheter Revision Kit	11830	FDA UDI	Class III	Active
Prometra Programmer	12828	FDA UDI	Class III	Active
Prometra Refill Kit	11825	FDA UDI	Class III	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Flowonix Medical, Inc. has 13 recall records initiated between May 22, 2017, and May 26, 2021. The records include statuses classified as open, classified, and terminated. The reasons cited involve firmware and software issues, such as pump alarm anomalies, unexpected shutdowns due to error codes, and potential misinterpretation of physician order forms. One report referenced a design feature related to MRI procedures.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 26, 2021	Z-1996-2021	—	terminated	Physician 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
Dec 24, 2019	Z-1121-2020	—	open, classified	A 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.
Dec 24, 2019	Z-1120-2020	—	open, classified	A 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.
Dec 24, 2019	Z-1125-2020	—	open, classified	A 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.
Dec 24, 2019	Z-1123-2020	—	open, classified	A 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.
Dec 24, 2019	Z-1124-2020	—	open, classified	A 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.
Dec 24, 2019	Z-1122-2020	—	open, classified	A 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.
Mar 21, 2019	Z-1716-2019	—	terminated	The 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.
Mar 21, 2019	Z-1714-2019	—	terminated	The 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.
Mar 21, 2019	Z-1715-2019	—	terminated	The 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.
Mar 21, 2019	Z-1712-2019	—	terminated	The 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.
Mar 21, 2019	Z-1713-2019	—	terminated	The 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.
May 22, 2017	Z-2740-2017	—	terminated	Flowonix 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.