Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly
Flowonix Medical Inc is recalling Prometra II 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms for 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 is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Flowonix Medical Inc is recalling the Prometra II 20mL Pump (Catalog No. 13827) under FDA recall number Z-1121-2020. The recall involves 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 devices are implantable infusion pumps manufactured from 2012 until the present time with pump firmware version 0.26.
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. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Patients with these devices should contact their healthcare provider or Flowonix Medical Inc for instructions on how to proceed. The recall is classified as FDA Class II, 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 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
- 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 II Pump Recall for Firmware Alarm Defect
FDA (Devices) · 2020-02-19
- HighFlowonix Prometra Implantable Pump Recall for Firmware Alarm Anomaly
FDA (Devices) · 2020-02-19
- HighFlowonix US Clinical 20mL Programmable Pump Recall for Firmware Alarm Defect
FDA (Devices) · 2020-02-19
Same hazard · firmware defect
See all →- HighAbiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects
FDA (Devices) · 2026-09-30
- 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
Similar recalls
- HighFlowonix Prometra II Pump Recall for Unexpected Shutdowns
FDA (Devices) · 2019-06-12
- CriticalFlowonix Recalls Prometra II Pump After Reported Fatal Overdose During MRI
FDA (Devices) · 2017-07-26
- HighFlowonix Prometra Programmable Pump Recalled for Unexpected Shutdowns
FDA (Devices) · 2019-06-12
- HighFlowonix Prometra Clinician Programmer Software Recall for Unexpected Pump Shutdowns
FDA (Devices) · 2019-06-12
- HighFlowonix Prometra Programmer Software Recall for Unexpected Pump Shutdowns
FDA (Devices) · 2019-06-12
- HighInfusion Pump Order Form Discontinued Due to Ambiguous Reuse Instructions
FDA (Devices) · 2021-07-07