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Prometra Refill Kit 11825Recalls & reported problems

Flowonix Medical, Inc. · The Refill Kit is sterile and provides the components and instructions necessary to access the pump reservoir to empty and fill the Prometra Programmable Pump. The drug chamber is refillable and is percutaneously accessed via the centrally-located access port using a 22-gauge non-coring needle. · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810335020143), received between Aug 14, 2020 and Aug 14, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Obstruction of Flow1
  • Use of Device Problem1

Patient problems

  • Decreased Respiratory Rate1
  • Hypoventilation1
  • Hypoxia1
  • Loss of consciousness1
  • Overdose1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 14, 2020Use of Device Problem; Obstruction of Flow; Use of Device Problem; Obstruction of Flow

    RECEIVED VOLUNTARY MEDWATCH, USER FACILITY REPORT # (B)(4), FORWARDED FROM AGENT WHO HAD RECEIVED THE REPORT FROM THE HEALTH PROFESSIONAL. MEDWATCH STATES, "RN ACCESSED PAIN PUMP FOR REFILL PROCEDURE. EXPECTED 6.2 ML RETURN OF FENTANYL FROM PROMETRA II PUMP. NO RETURN NOTED BUT CLEARLY ACCESSED CORRECTLY. 2ND RN EVALUATED. NEEDLE PULLED BACK AND REASSESSED PUMP. NO RETURN OF FENTANYL AGAIN. NEW REFILL KIT UTILIZED TO ACCESS PAIN PUMP. PUMP ACCESSED EASILY. ESTIMATED 4.8ML OF FENTANYL RETURNED INTO SYRINGE. REFILL PROCESS COMPLETED. WITHIN 5-8 MINUTES OF INITIAL ACCESS, PATIENT DEMONSTRATED DECREASING LEVEL OF CONSCIOUSNESS. PATIENT ASSISTED TO LIE DOWN ON EXAM TABLE. PATIENT NOTED TO BE DIAPHORETIC. EMERGENCY RESPONSE ENGAGED. PATIENT NOT RESPONSIVE TO STERNAL RUB, OXYGEN SATURATION DOWN TO 70'S, AND SPONTANEOUS RESPIRATIONS DECLINING TO AGONAL BREATHS. ASSISTED VENTILATION WITH BAG/MASK VENTILATION WITH 100% SUPPLEMENTAL OXYGEN. BLOOD GLUCOSE CHECKED AND WITHIN NORMAL RANGES. PUPILS PINPOINT. IV STARTED AND NARCAN ADMINISTERED. PATIENT RESPONDED WELL AFTER DOSE OF NARCAN. FULLY AWAKE AND ORIENTED. PHYSICIAN EVALUATED PUMP ACCESS SITE AND WAS NOT ABLE TO PALPATE ANY OBVIOUS SUBCUTA

    Patient problems: Decreased Respiratory Rate; Hypoventilation; Hypoxia; Loss of consciousness; Overdose

    MAUDE report 10406642 ↗

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 Mode
  • 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-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-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-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-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-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-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-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-1715-2019 · Mar 21, 2019 · Terminated
    Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
  • Z-1716-2019 · Mar 21, 2019 · Terminated
    Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
  • Z-1714-2019 · Mar 21, 2019 · Terminated
    Prometra Programmable Pump, Cat. No. 11827 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

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Sources and updates

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