Flowonix Prometra Implantable Pump Recall for Firmware Alarm Anomaly
Flowonix Medical Inc is recalling Prometra Programmable 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms during valve system issues.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could prevent safety alarms from sounding, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Flowonix Medical Inc is recalling the Prometra Programmable 20mL Pump, an implantable infusion pump (Catalog No. 91827). The recall affects 1,083 units distributed domestically in the United States and internationally to the United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium. The affected units are those with pump firmware version 0.26 manufactured from 2012 until the present time.
The recall is due to a pump alarm function anomaly in the firmware code. This defect may result in the pump not sending expected error code notifications to the Programmer or failing to emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
Patients with these devices should contact their healthcare provider or Flowonix Medical Inc for instructions on how to proceed. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
- Manufacturer
- Flowonix Medical Inc
- Hazard
- Affected units
- 1,083
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Flowonix Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Flowonix Medical Inc
See all →- HighInfusion Pump Order Form Discontinued Due to Ambiguous Reuse Instructions
FDA (Devices) · 2021-07-07
- HighFlowonix Prometra II Pump Recall for Firmware Alarm Anomaly
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- HighFlowonix Prometra II Pump Recall for Firmware Alarm Defect
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- HighFlowonix Prometra II Pump Recall for Firmware Alarm Anomaly
FDA (Devices) · 2020-02-19
- HighFlowonix US Clinical 20mL Programmable Pump Recall for Firmware Alarm Defect
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- High
- ModeratePhilips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue
FDA (Devices) · 2026-06-10
Similar recalls
- HighFlowonix Prometra Programmable Pump Recalled for Unexpected Shutdowns
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- HighFlowonix Prometra II Pump Recall for Unexpected Shutdowns
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- CriticalFlowonix Recalls Prometra II Pump After Reported Fatal Overdose During MRI
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- HighFlowonix Prometra Clinician Programmer Software Recall for Unexpected Pump Shutdowns
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