Flowonix recalls Prometra Programmable Pump (Cat. No. 11827) for intrathecal infusion due to unexpected shutdowns when Error 115 occurs, caused by software defects in specific programming scenarios.
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.
Take action
Contact the company
📍Recalling firmFlowonix Medical Inc120 Forbes Blvd Ste 170 · Mansfield, MA 02048-1150
✎ GovInfoNow plain-language explainer
Flowonix is recalling its Prometra Programmable Pump (Cat. No. 11827) for intrathecal infusion because a software defect can cause it to shut down unexpectedly when Error 115 is triggered. This error can happen if a healthcare provider programs a Bridge or Demand bolus using Clinician Programmer Software Version 2.00.29 while the pump is set to Periodic Flow or Multiple Rates mode, or if dendrites form or the pump is dropped. Read more at govinfonow.com/recall/68577-flowonix-prometra-programmable-pump-recall-error-115-shutdown-risk.
“Flowonix Prometra Programmable Pump Recall: Error 115 Shutdown Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68577-flowonix-prometra-programmable-pump-recall-error-115-shutdown-risk. Based on FDA recall #Z-1714-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1714-2019%22&limit=1).
The FDA announced on March 21, 2019, that Flowonix Medical Inc is recalling Prometra Programmable Pumps because the device may shut down unexpectedly. Owners should contact the company for a remedy.
Serial Numbers: 10AX4A03 through 10KY4A99 (see record for full list)
The hazard
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. This error can occur due to a software defect when using Clinician Programmer Software Version 2.00.29 to program a Bridge or Demand bolus while the pump is set to Periodic Flow or Multiple Rates flow mode. Error 115 can also be caused by dendrite formation or if the pump is dropped.
Context
GovInfoNow's records show Flowonix Medical Inc has two other recalls on record since December 24, 2019. On May 26, 2021, the company issued a recall for a Physician Order Form due to misinterpreted text risk. Other recent recalls of similar products include Baxter Novum IQ Syringe Pump Recall (August 11, 2026), Fresenius Kabi Ivenix Infusion System Software Recall (May 6, 2026), and Fresenius Kabi Ivenix Infusion Pump Recall (November 3, 2025).
How to tell if you have this one
Check the pump's serial number against the list provided: 10AX4A03, 10BY4A40, 10EY4A35, and other serial numbers listed in the recall notice. This pump is for intrathecal infusion and was sold with specific software versions.
Brand
Flowonix
Category
Medical device
FDA recall event · 5 products
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1714-2019 (March 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1714-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.