Flowonix recalls Prometra II Programmable Pumps (Cat. No. 01827) for intrathecal infusion due to unexpected shutdowns when Error 115 occurs from software defects. Affected units have specific serial numbers listed in the recall.
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.
Flowonix is recalling Prometra II Programmable Pumps (Cat. No. 01827) used for intrathecal infusion because a software defect can cause the pump to shut down unexpectedly. This could lead to interrupted medication delivery if the pump stops working during treatment.
The pump can shut down unexpectedly when Error 115 occurs, which is triggered by a software defect. This defect happens if a healthcare provider uses a specific software version to program a Bridge or Demand bolus while the pump is set to Periodic Flow or Multiple Rates mode. It can also occur if dendrites form or the pump is dropped.
Patients using the Prometra II pump for intrathecal medication delivery are most at risk. Healthcare providers who programmed the pump with certain software versions may also be affected.
Check if your pump has the serial numbers listed in the recall (e.g., 10ET4A02, 36AR4A11, etc.). The pump is used for intrathecal infusion and has the model number Prometra II Programmable Pump (Clinical), Cat. No. 01827.
Compare your pump's serial number to the list of affected units provided in the recall.
Reach out to Flowonix Medical Inc for further guidance on next steps.
The pump may shut down unexpectedly due to Error 115, which can occur from a software defect when programming with specific settings or if the pump is dropped or dendrites form.
The software version 2.00.29 of the Clinician Programmer caused the defect when programming Bridge or Demand bolus while the pump is set to Periodic Flow or Multiple Rates mode.
Check if your pump's serial number is listed in the recall (e.g., 10ET4A02, 36AR4A11, etc.). The pump is used for intrathecal infusion and has the model number Prometra II Programmable Pump (Clinical), Cat. No. 01827.
We’ve drafted a message you can send Flowonix to request your refund or repair — edit it as you like.
Subject: Recall Z-1716-2019 — Flowonix Flowonix Hello, I own a Flowonix that is covered by recall Z-1716-2019 from Flowonix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
