Prometra II (Flowonix Medical Inc) – a pump alarm function anomaly in the ... (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Brand
Flowonix Medical Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10GC4A24X 10GC4A02X 10GC4A18X 10GC4A22X 10GC4A14X 4MA00044X 4MA00006X 10GC4A12X 10GC4A09X 10GC4A06X 10GC4A21X 4MA00008X 10GC4A01X 10GC4A20X 10GC4A11X 10GC4A16X 10GC4A17X 4MA00045X 4MA00055X 10GC4A08X 4MA00032X 4MA00031X 4MA00010X 4MA00042X
Flowonix Medical Inc is recalling Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 0081033 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. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
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
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
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: Mar 8, 2026