Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PROMETRA II Programmable Infusion Pump Recalled by Flowonix Medical, Inc. Due to Flowonix Medical received a report of a patient...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Flowonix Medical, Inc. directly.
Affected Products
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 revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).
Quantity: US: 2204 units
Why Was This Recalled?
Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to permit safe exposure to an MRI without removing drug from the reservoir.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Flowonix Medical, Inc.
Flowonix Medical, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report