Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly
Flowonix Medical Inc is recalling Prometra II 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms for valve system issues.
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. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Flowonix Medical Inc is recalling the Prometra II 20mL Pump (Catalog No. 13827) under FDA recall number Z-1121-2020. The recall involves 6,670 units distributed domestically in the United States and internationally to the United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium. The affected devices are implantable infusion pumps manufactured from 2012 until the present time with pump firmware version 0.26.
The recall is due to a pump alarm function anomaly in the firmware code. This defect may result in the pump not sending expected error code notifications to the Programmer or failing to emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Patients with these devices should contact their healthcare provider or Flowonix Medical Inc for instructions on how to proceed. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
- Manufacturer
- Flowonix Medical Inc
- Affected units
- 6,670
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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