Flowonix Prometra II Pump Recall for Unexpected Shutdowns
Flowonix Medical Inc. is recalling 163 Prometra II Programmable Pumps due to a software defect that can cause unexpected shutdowns.
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 is classified as FDA Class II. The hazard involves a medical device that may fail to deliver medication, which is a risk-of-harm product where injury has not yet been reported in the source text.
Plain-English summary
Flowonix Medical Inc. is recalling 163 units of the Prometra II Programmable Pump (Clinical), Catalog No. 01827, used for intrathecal infusion. The recall is due to a software defect that can cause the pump to shut down unexpectedly if Error 115 is triggered.
The defect is associated with a watchdog timer timeout. Error 115 occurrences have increased when a Healthcare Provider uses a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
The affected pumps were distributed nationwide in the United States. Healthcare providers and patients should check their pump serial numbers against the list provided in the official recall notice. If a pump is affected, they should contact Flowonix Medical Inc. for instructions on how to proceed.
The recalled product
- Product
- Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
- Manufacturer
- Flowonix Medical Inc
- Category
- Medical Device — Infusion Pump
- Affected units
- 163
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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