Flowonix Recalls Prometra II Pump After Reported Fatal Overdose During MRI
Flowonix Medical is recalling Prometra II implantable infusion pumps after a report of a fatal drug overdose during an MRI procedure.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly reports a 'fatal drug overdose,' which meets the rubric criterion for a score of 5 (Critical) due to known fatalities.
Plain-English summary
Flowonix Medical, Inc. is recalling the Prometra II Programmable Infusion Pump, an implantable device used for intrathecal infusion of morphine sulfate or saline. The recall involves 2,204 units distributed nationwide in the United States.
The recall was initiated after Flowonix Medical received a report of a patient implanted with the Prometra II pump who may have received a fatal drug overdose during an MRI procedure. The device includes an FDA-approved design feature intended to allow safe exposure to MRI without removing drug from the reservoir.
Patients with implanted Prometra II pumps should contact their healthcare provider for instructions on how to proceed. The recall covers the pump and associated labeling materials, including instructions for use for catheters, kits, and patient guides.
The recalled product
- Product
- PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being…
- Manufacturer
- Flowonix Medical, Inc.
- Affected units
- 2,204
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All
Distribution
Distributed nationwide across the United States.
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