Flowonix Prometra Programmer Software Recall for Unexpected Pump Shutdowns
Flowonix Medical Inc is recalling 40 units of Prometra Programmer software due to a defect that causes intrathecal pumps to shut down unexpectedly.
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 the hazard involves the unexpected shutdown of a medical device used for intrathecal infusion, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Flowonix Medical Inc is recalling 40 units of Prometra Programmer (Grand Prime) Software version 2.00.29, Catalog Number 13828. This software is used with Prometra and Prometra II Programmable Pumps for intrathecal infusion. The affected units were distributed nationwide in the United States.
The recall is due to a software defect that causes the pump to shut down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. The frequency of these errors has increased when a Healthcare Provider uses the Clinician Programmer software to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
Healthcare providers and patients using the affected software should contact Flowonix Medical Inc for further instructions on how to address the software defect and ensure the safety of their intrathecal infusion therapy.
The recalled product
- Product
- Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
- Manufacturer
- Flowonix Medical Inc
- Affected units
- 40
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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 5 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 Programmable 20mL Pump Recalled 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 · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12