Flowonix Prometra II Pump Recall for Unexpected Shutdowns
Flowonix Medical Inc is recalling 6,445 Prometra II Programmable Pumps because a software defect can cause the device to shut down unexpectedly.
The agency’s classification
FDA (Devices): Class II
Class II is 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 is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device that may fail to deliver medication as intended (unexpected shutdown), which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Flowonix Medical Inc is recalling 6,445 units of the Prometra II Programmable Pump, Catalog Number 13827, which is used for intrathecal infusion. The recall is due to a software defect that can cause the pump to shut down unexpectedly if a specific alarm, Error 115, is triggered.
The defect occurs when a Healthcare Provider uses a Clinician Programmer with 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, which is associated with a watchdog timer timeout, has increased in frequency due to this specific programming interaction. The error can also occur if dendrites form or if the pump is dropped.
The affected pumps were distributed nationwide in the United States. Patients using these devices should contact their healthcare provider for instructions on how to proceed with the recall.
The recalled product
- Product
- Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
- Manufacturer
- Flowonix Medical Inc
- Affected units
- 6,445
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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.
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