Flowonix Prometra II Pump Recall for Firmware Alarm Defect
Flowonix Medical Inc is recalling Prometra II 40mL implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.
What this means for you
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 is classified as FDA Class II and involves a risk-of-harm product (implantable infusion pump) where the failure to alarm could lead to adverse health consequences, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Flowonix Medical Inc is recalling the Prometra II 40mL Pump (Catalog No. 16827) due to a pump alarm function anomaly in the firmware code. The 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.
The recall affects 6,670 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. Specific serial numbers are listed in the agency's recall record.
Patients with these implantable devices should contact their healthcare provider or Flowonix Medical Inc for instructions on evaluation and potential replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
- Manufacturer
- Flowonix Medical Inc
- Affected units
- 6,670
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
FDA (Devices) · 2020-02-19
- HighFlowonix Prometra Programmable 20mL Pump Recalled for Firmware Alarm Anomaly
FDA (Devices) · 2020-02-19
- HighFlowonix Prometra II Pump Recall for Firmware Alarm Anomaly
FDA (Devices) · 2020-02-19
- HighFlowonix Prometra Implantable Pump Recall for Firmware Alarm Anomaly
FDA (Devices) · 2020-02-19
Same hazard · firmware defect
See all →- HighParagonix KidneyVault Portable Renal Perfusion System Recalled for Firmware Defect
FDA (Devices) · 2026-08-26
- HighPhilips Allura Xper FD Fluoroscopic X-Ray System Recalled for Firmware Issue
FDA (Devices) · 2026-08-19
- HighPermobil M3 Corpus Power Wheelchair Recalled Over Firmware Stability Issue
FDA (Devices) · 2026-08-05
- HighiLet Bionic Pancreas pumps may become stuck on the lock screen
FDA (Devices) · 2026-06-24
- HighNatus SD LTM 64 PLUS EEG recorders may shift traces one second
FDA (Devices) · 2026-06-17