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Prometra Programmable Infusion Pump System

by Infusyn Therapeutics, LLC

PMA P080012

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

PMA P080012↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP080012 Date7 Feb 2012ApprovedStatusActive

Recalls

13 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-1124-2020 FDA Class II initiated 24 Dec 2019
    • Ongoing Z-1122-2020 FDA Class II initiated 24 Dec 2019
    • Ongoing Z-1123-2020 FDA Class II initiated 24 Dec 2019
    • Ongoing Z-1120-2020 FDA Class II initiated 24 Dec 2019
    • Ongoing Z-1125-2020 FDA Class II initiated 24 Dec 2019
    • Ongoing Z-1121-2020 FDA Class II initiated 24 Dec 2019

    A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

    • Terminated Z-1996-2021 FDA Class II initiated 26 May 2021

    Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as 'reuse the same drug solution extracted from the pump prior to the MRI procedure', creating a possible risk of infection

  • 3 recalls, same reason

    • Terminated Z-1714-2019 FDA Class II initiated 21 Mar 2019
    • Terminated Z-1715-2019 FDA Class II initiated 21 Mar 2019
    • Terminated Z-1716-2019 FDA Class II initiated 21 Mar 2019

    The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, 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 can also occur if dendrites form or if the pump is dropped.

  • 2 recalls, same reason

    • Terminated Z-1712-2019 FDA Class II initiated 21 Mar 2019
    • Terminated Z-1713-2019 FDA Class II initiated 21 Mar 2019

    The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, 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.

    • Terminated Z-2740-2017 FDA Class II initiated 22 May 2017

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Pump, infusion, implanted, programmable
PMA Number
FDA Product Code
LKK
Device Class
Class III
Advisory Committee
General Hospital
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Prometra Programmable Infusion Pump System is an implanted, programmable infusion pump. It is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution.

The device is supplied as an implanted system and is intended for use in general hospital settings. It has received FDA PMA approval (P080012) and is classified as a Class III device. Sterility, MRI safety, storage conditions, and reusability are not specified in the provided data.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Prometra Programmable Infusion Pump System indicated for?

    The device is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution, as stated in the approval documentation.

  • Who manufactures the Prometra Programmable Infusion Pump System?

    The Prometra Programmable Infusion Pump System is manufactured by Infusyn Therapeutics, LLC, located in Hackettstown, New Jersey.

  • What regulatory authorization does the Prometra Programmable Infusion Pump System have?

    The device has received FDA Premarket Approval (PMA) under number P080012, with approval granted on February 7, 2012.