Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Prometra II Programmable Pump (Clinical) Recalled by Flowonix Medical Inc Due to The pump shuts down unexpectedly if Error 115,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Flowonix Medical Inc directly.
Affected Products
Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
Quantity: 163
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Flowonix Medical Inc
Flowonix Medical Inc has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report