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Prometra Programmer 12828Recalls & reported problems

Flowonix Medical, Inc. · The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the implantable Programmable Pump using a touchscreen interface. The Programmer can program the pump to deliver a precise flow of medication at a constant or variable rate, or it can be set to periodically deliver a drug dosage at distinct intervals of time (i.e., Periodic Flow Mode). There is also an option to interrupt the pump's current medication regimen and deliver an immediate infusion of medication (Demand Bolus). · Class 3

Adverse event reports
10
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00810335020167), received between Mar 3, 2016 and Aug 6, 2019 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (9 reports).

13 other recalls cover devices cleared under the same FDA submission (P080012); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Display or Visual Feedback Problem9
  • Excess Flow or Over-Infusion1

Patient problems

  • No Consequences Or Impact To Patient7
  • No Patient Involvement1
  • Overdose1
  • Pain1
  • Patient Problem/Medical Problem1

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 6, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    IT WAS REPORTED THAT CLINICIAN PROGRAMMER WAS MALFUNCTIONED RESULTING IN AN OVER INFUSION AND PATIENT HOSPITALIZATION.

    Patient problems: Overdose; Patient Problem/Medical Problem

    MAUDE report 8864286 ↗
  • MalfunctionAug 31, 2016Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT THE PROGRAMMER SCREEN INCORRECTLY DISPLAYED THE PUMP RESERVOIR VOLUME DURING AN APPOINTMENT. TROUBLESHOOTING WAS PERFORMED, AND THE ISSUE APPEARED TO HAVE BEEN RESOLVED. IT WAS NOTED THAT THE PATIENT COMPLAINED OF INCREASED PAIN AFTER THE PREVIOUS APPOINTMENT.

    Patient problems: Pain

    MAUDE report 5917246 ↗
  • MalfunctionMar 24, 2016Display or Visual Feedback Problem; Display or Visual Feedback Problem

    DURING A SCHEDULED REFILL APPOINTMENT, IT WAS REPORTED THAT THE PROGRAMMER SCREEN INCORRECTLY DISPLAYED THE PUMP RESERVOIR VOLUME. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE APPEARED TO HAVE BEEN RESOLVED. THERE WERE NO PATIENT EFFECTS REPORTED AND THE DEVICE WILL NOT BE RETURNED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5524479 ↗
  • MalfunctionMar 18, 2016Display or Visual Feedback Problem; Display or Visual Feedback Problem

    THE PROGRAMMER DISPLAYED VARIOUS PUMP DETAILS INCORRECTLY FOLLOWING PUMP INQUIRIES. THERE WERE NO PATIENT EFFECTS REPORTED AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5509633 ↗
  • MalfunctionMar 18, 2016Display or Visual Feedback Problem; Display or Visual Feedback Problem

    DURING AN INITIAL PUMP INQUIRY, IT WAS REPORTED THAT THE VOLUME WAS INCORRECTLY DISPLAYED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Patient Involvement

    MAUDE report 5509632 ↗
  • MalfunctionMar 17, 2016Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT THE INQUIRY SCREEN DISPLAYED INCORRECT VALUES DURING AN INQUIRY SESSION. AT THE SUBSEQUENT APPOINTMENT, TROUBLESHOOTING WAS PERFORMED AND THE ISSUE APPEARED TO HAVE BEEN RESOLVED. THERE WERE NO PATIENT EFFECTS REPORTED AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5509615 ↗
  • MalfunctionMar 17, 2016Display or Visual Feedback Problem; Display or Visual Feedback Problem

    THE PROGRAMMER DISPLAYED VARIOUS PARAMETERS INCORRECTLY FOLLOWING PUMP INQUIRIES. THERE WERE NO PATIENT EFFECTS REPORTED AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5509613 ↗
  • MalfunctionMar 17, 2016Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT THE PROGRAMMER PRINTOUTS DISPLAYED INCORRECT INFORMATION. THERE WERE NO PATIENT EFFECTS REPORTED AND THE DEVICE WAS RETURNED FOR EVALUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5509612 ↗
  • MalfunctionMar 17, 2016Display or Visual Feedback Problem; Display or Visual Feedback Problem

    DURING A SCHEDULED REFILL APPOINTMENT, IT WAS REPORTED THAT THE VOLUME WAS INCORRECT ON THE PROGRAMMER DISPLAY. THE PATIENT'S PUMP WAS REFILLED AND THE PATIENT WAS SENT HOME. ON (B)(6) 2015, IT WAS REPORTED THAT THE ISSUE HAD NOT REOCCURRED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5509611 ↗
  • MalfunctionMar 3, 2016Display or Visual Feedback Problem; Display or Visual Feedback Problem

    DURING AN INITIAL PUMP INQUIRY, THE PROGRAMMER DISPLAYED INCORRECT INFORMATION. AFTER A FEW TROUBLESHOOTING ATTEMPTS, THE PROGRAMMER APPEARED TO HAVE CORRECTLY DISPLAYED MOST OF THE INCORRECT INFORMATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5477748 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P080012. One submission often covers many models, so check the product and lot details in each record.

  • Z-1996-2021 · May 26, 2021 · Terminated
    Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US M
  • Z-1124-2020 · Dec 24, 2019 · Open, Classified
    Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
  • Z-1125-2020 · Dec 24, 2019 · Open, Classified
    Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
  • Z-1120-2020 · Dec 24, 2019 · Open, Classified
    Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
  • Z-1121-2020 · Dec 24, 2019 · Open, Classified
    Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
  • Z-1122-2020 · Dec 24, 2019 · Open, Classified
    Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
  • Z-1123-2020 · Dec 24, 2019 · Open, Classified
    US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
  • Z-1716-2019 · Mar 21, 2019 · Terminated
    Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
  • Z-1713-2019 · Mar 21, 2019 · Terminated
    Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
  • Z-1715-2019 · Mar 21, 2019 · Terminated
    Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
  • Z-1714-2019 · Mar 21, 2019 · Terminated
    Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
  • Z-1712-2019 · Mar 21, 2019 · Terminated
    Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
  • Z-2740-2017 · May 22, 2017 · Terminated
    PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction i

Other Pump, Infusion, Implanted, Programmable devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.