Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly
Flowonix Medical Inc is recalling Prometra II implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where the failure to alarm could lead to injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Flowonix Medical Inc is recalling the Prometra II Programmable 20mL Pump, an implantable infusion pump. The recall affects 1,083 units distributed domestically in the United States and internationally to the United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.
The recall is due to a pump alarm function anomaly in the firmware code. This issue may result in the pump not sending expected error code notifications to the Programmer or not emitting an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system. The affected units are those with pump firmware version 0.26 manufactured from 2012 until the present time.
Patients with these devices should contact their healthcare provider or Flowonix Medical Inc for instructions on how to proceed. The agency has classified this as a Class II recall.
The recalled product
- Product
- Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
- Manufacturer
- Flowonix Medical Inc
- Affected units
- 1,083
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Flowonix Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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