Flowonix Medical Inc Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
Brand
Flowonix Medical Inc
Lot Codes / Batch Numbers
All units with pump firmware version 0.26 manufactured from 2012 until the present time.
Products Sold
All units with pump firmware version 0.26 manufactured from 2012 until the present time.
Flowonix Medical Inc is recalling Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. G due to A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
Recommended Action
Per FDA guidance
***Updated 5/12/2023*** On May 11, 2023, the firm sent an URGENT MEDICAL DEVICE CORRECTION UPDATE letter to all affected customers, which informed them of an update to Flowonix's plan to correct the firmware issue. Flowonix will NOT be conducting an office-based pump firmware update for affected pumps implanted prior to January 2020. Healthcare providers were provided ongoing recommendations for Prometra and Prometra II pumps implanted prior to January 2020, which are impacted by this issue. Healthcare providers should contact their Flowonix Representative or our Technical Solutions Department (1-855-356-9665) in the event cessation of therapy or premature low battery is suspected and/or have general questions regarding this notice. *** On December 24, 2019, the firm notified affected users via an Urgent Medical Device Corrective Action Recall Notice. The firm advised customers of the product issue and reminded customers that the pumps are currently labeled only for use with Infumorph. Due to the low risk that this failure mode may occur, Flowonix is not recommending that pumps be explanted. Healthcare providers were recommended to inform patients regarding the symptoms and adverse health events associated with an unexpected pump stoppage and the appropriate steps to take in the event they suspect a stoppage. The firm will be implementing a correction of firmware errors to bring the pumps back into specification. The firm will follow up when the change has been completed. An office-based pump firmware update is being developed for patients currently implanted with the affected pumps. (Note, as of the 5/12/23 update, implanted pumps will not be receiving a firmware update.)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026