Prometra Programmable PumpRecalls & reported problems across all models
Flowonix Medical, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 115
- Deaths reported
- 9
- Injuries reported
- 88
- Recalls
- 0
We found 2 models of Prometra Programmable Pump by Flowonix Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 115 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2015 and Jun 6, 2023 — classified as 9 deaths, 88 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (26 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Prometra Programmable Pump problems
Device problems
- Adverse Event Without Identified Device or Use Problem43
- Insufficient Flow or Under Infusion26
- Device Operates Differently Than Expected15
- Device Dislodged or Dislocated6
- Insufficient Device Problem Information6
- Device Displays Incorrect Message5
- Device Issue5
- Excess Flow or Over-Infusion5
Patient problems
- Inadequate Pain Relief30
- Patient Problem/Medical Problem21
- Pain12
- No Code Available11
- Death9
- Discomfort9
- No Clinical Signs, Symptoms or Conditions9
- No Known Impact Or Consequence To Patient7
Prometra Programmable Pump models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prometra Programmable Pump 11827Pump, Infusion, Implanted, Programmable9 deaths83 reports
- Prometra Programmable Pump 16827Pump, Infusion, Implanted, Programmable32 reports
Recent Prometra Programmable Pump adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 6, 2023Pumping Stopped; Pumping Stopped
PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A PUMP REPLACEMENT. THE REASON FOR REPLACEMENT WAS REPORTED TO BE A LACK OF SUFFICIENT PAIN RELIEF. ADDITIONAL COMMUNICATION WITH THE AGENT CONFIRMED THAT THE PATIENT'S PUMP WAS STOPPED WITH ERROR CODE 100 AND 115, ALTHOUGH THE OFFICE DID NOT REPORT THIS UNTIL THE TIME OF REPLACEMENT. THEREFORE, TROUBLESHOOTING WAS NOT PERFORMED. THE PUMP WAS DISCARDED AFTER IT WAS REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 17071403 ↗InjuryJun 5, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A PUMP REPLACEMENT. THE REASON FOR REPLACEMENT WAS REPORTED TO BE A LACK OF THERAPY. AGENT REPORTED THAT AN UNDERINFUSION WAS ALLEGED AS WELL, THE EXPECTED VOLUME WAS 7ML AND THE ACTUAL ASPIRATED VOLUME WAS 20ML. THE DEVICE WAS DISCARDED.
Patient problems: Inadequate Pain Relief
MAUDE report 17060481 ↗InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT TRACKING RECEIVED A TRACKING FORM IN THE MAIL REPORTING A REVISION SURGERY. A CATHETER WAS REPLACED AND DISCARDED WHILE THE PATIENT'S PUMP WAS MOVED FROM THEIR ABDOMEN TO THEIR RIGHT BUTTOCKS. FOLLOW-UP COMMUNICATION WAS SENT TO THE REPRESENTATIVE REQUESTING THE REASON FOR PUMP RELOCATION. REPRESENTATIVE REPORTED THAT THE REVISION OCCURRED DUE TO "PATIENT COMFORT," CONFIRMED TO BE RELATED TO UNANTICIPATED DISCOMFORT REPORTED BY THE PATIENT RATHER THAN INAPPROPRIATE INITIAL PLACEMENT OF THE PUMP.
Patient problems: Discomfort
MAUDE report 16693455 ↗InjuryFeb 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REVISION. THE REASON FOR REVISION WAS DUE TO PUMP FLIPPING. ADDITIONAL COMMUNICATION WITH THE REPORTER OF THE ISSUE CONFIRMED THAT THE PATIENT'S PUMP WAS INITIALLY SUTURED DOWN, BUT THEN BEGAN FLIPPING. THE REPORTER STATED THAT THE ISSUE WAS DIAGNOSED WHEN THE CLINIC WAS TRYING TO PERFORM A REFILL AND THE PROGRAMMER WASN'T READING THE PUMP. THE REPORTER STATED THAT THE DEVICE HAD TO BE MANUALLY FLIPPED TO PERFORM THE REFILL. THE REPORTER STATED THAT THE PUMP IS NOW SUTURED DOWN TO THE MUSCLE AS OPPOSED TO THE FAT TO ENSURE THAT THE PUMP FLIPPING WOULD NOT HAPPEN AGAIN. NO DEVICES WILL BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16385631 ↗MalfunctionFeb 16, 2023Pumping Stopped; Pumping Stopped
REPORTER CONTACTED TECHNICAL SOLUTIONS TO REPORT ERROR CODES 100, 103, AND 116 THAT SHOWED WHEN THEY ATTEMPTED TO INQUIRE A PATIENT'S PUMP. THEY REPORTED THAT THEY HAD EMPTIED AND REFILLED THE PUMP PRIOR TO INQUIRING IT, AND THE ERROR CODES APPEARED WHEN THEY FIRST ATTEMPTED INQUIRY. REPORTER STATED THAT THE PATIENT WAS HOSPITALIZED DUE TO PNEUMONIA FOR SEVERAL WEEKS PRIOR TO THIS EVENT. THE PATIENT REPORTED INCREASED SPASMS THAT STARTED TWO WEEKS AGO, AROUND THE TIME THEY HAD A CT SCAN. THE PATIENT ALSO REPORTED SPASMS IN THEIR STOMACH, WHICH THEY HAD NOT EXPERIENCED BEFORE. REPORTER STATED THAT THE PATIENT HAS NOT UNDERGONE ANY MRIS RECENTLY AND THAT THEIR ORAL DOSE OF NEURONTIN HAD RECENTLY BEEN DECREASED. TECHNICAL SOLUTIONS ASKED THE REPORTER TO PROGRAM AN "EMERGENCY PUMP STOP" FOLLOWED BY A DEMAND BOLUS OF 0 MG FOR 1 MINUTE. REPORTER WAS ABLE TO PROGRAM THE PUMP STOP, BUT THE PROGRAMMER DISPLAYED "PUMP COMMUNICATION FAILED" EACH TIME THEY TRIED TO ENTER THE BOLUS MENU. REPORTER ATTEMPTED THIS THREE TIMES, EACH WITH THE SAME RESULT. TECHNICAL SOLUTIONS PROVIDED THE REPORTER WITH CONTACT INFORMATION FOR THE DIRECTOR OF CLINICAL ENGINEERING SO THE REPORTER COULD COORDINATE A TIM
Patient problems: Cramp(s) /Muscle Spasm(s)
MAUDE report 16385630 ↗InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FLOWONIX INITIALLY RECEIVED A REPORT ABOUT A PATIENT ALLEGING UNRELIEVED PAIN AND A POTENTIAL DEVICE MALFUNCTION. THE AGENT COVERING THE ISSUE REPORTED THAT THERE WERE NO VOLUME DISCREPANCIES. THE AGENT REPORTED THAT THE OFFICE INCREASED THE DAILY DOSE BY 1-2% EACH VISIT, AND THE PATIENT WAS THEN SCHEDULED TO HAVE A DYE STUDY PERFORMED. A DYE STUDY WAS LATER PERFORMED, WHICH SHOWED THAT DRUG WAS NOT FLOWING FROM THE CATHETER. AGENT REPORTED THAT THE PATIENT REQUESTED THAT THE PUMP BE EXPLANTED AND KEPT IN THEIR POSSESSION. THE CATHETER ISSUE WAS CAPTURED IN MDR 3010079947-2021-00069. VOLUNTARY MW5114474 WAS LATER RECEIVED FROM FDA. REPORTER STATED THAT THEIR SPOUSE HAD PUMP IMPLANTED AFTER BEING DIAGNOSED WITH PANCREATIC CANCER. DOCTORS IMPLANTED A "PROMETRA FLOWONIX PUMP" WHICH "SEEMED TO STABILIZE [THE PATIENT'S] PAIN"; HOWEVER SHORTLY AFTERWARDS, REPORTER ALLEGED NEEDING TO RETURN TO THE HOSPITAL WITH THE PATIENT "TWICE WEEKLY/EVERY THREE DAYS." THE PATIENT WOULD HAVE THEIR MEDS INCREASED, ALTHOUGH "SEVERAL ER VISITS MORE HOSPITAL STAYS" WERE REPORTED. A NUCLEAR TEST WAS REPORTEDLY PERFORMED TO "CHECK THE DEVICE" AFTER "3 DAYS OF X-RAYS SHOWED THE DEVICE WAS NOT WORKING". PATIEN
Patient problems: Inadequate Pain Relief; Seroma
MAUDE report 16351807 ↗InjuryNov 17, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
NURSE CONTACTED TECHNICAL SOLUTIONS TO REPORT AN UNDERINFUSION VOLUME DISCREPANCY. THE PATIENT HAD BEEN COMPLAINING OF INCREASED PAIN OVER THE PREVIOUS WEEKS, AND WHEN A VOLUME CHECK WAS PERFORMED, THE EXPECTED VOLUME WAS 4.898ML AND THE ACTUAL ASPIRATED VOLUME WAS 18ML. THE PATIENT DID NOT REPORT ANY FALLS, TRAUMA, OR MRIS. LATER COMMUNICATION CONFIRMED THAT A DYE STUDY WAS PERFORMED AND THE CATHETER WAS FOUND TO BE PATENT. THE PUMP WAS LATER EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 15814213 ↗InjuryAug 1, 2022Communication or Transmission Problem; Migration; Communication or Transmission Problem; Migration
INFORMATION WAS RECEIVED REPORTING A PUMP REPLACEMENT. ADDITIONAL COMMUNICATION WITH REPRESENTATIVE CONFIRMED THAT THE PATIENT'S PUMP WAS REPORTED TO BE SIDEWAYS AND THE PHYSICIAN HAD TROUBLE READING AND REFILLING THE PUMP. REPRESENTATIVE STATED THAT THE CAUSE OF THE PUMP MIGRATION WAS NOT KNOWN, BUT THAT THE DEVICE WAS NO LONGER ANCHORED. REPRESENTATIVE ALSO STATED THAT THE PHYSICIAN DECIDED TO REPLACE RATHER THAN REVISE BECAUSE OF THE DEVICE AGE. DEVICE WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15138472 ↗InjuryJul 27, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT A PUMP REPLACEMENT FOR A PATIENT WHO HAD MULTIPLE VOLUME DISCREPANCIES. CS STATED THAT THE PATIENT WAS EXPERIENCING A LACK OF PAIN RELIEF. CS ALSO REPORTED THAT A DYE STUDY WAS PERFORMED THAT SHOWED THAT THE CATHETER WAS WORKING FINE.
Patient problems: Inadequate Pain Relief
MAUDE report 15115651 ↗MalfunctionJun 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
CS STATED THAT EVERY TIME THE PATIENT PRESSES THE RX BUTTON AND HOLDS IT OVER THE PUMP, THE PATIENT THERAPY CONTROLLER (PTC) READS UNABLE TO FIND THE PUMP. CS REPORTED THAT THE PATIENT WAS INITIALLY NOT ABLE TO DELIVER BOLUSES. CS LATER FOLLOWED UP AND CONFIRMED THAT THE PATIENT'S PUMP WAS FLIPPED AND THEIR PHYSICIAN'S ASSISTANT FLIPPED IT BACK AND WAS ABLE TO DELIVER A BOLUS SUCCESSFULLY. CS REPORTED THAT THE PATIENT'S PUMP WAS SUTURED DOWN AT IMPLANT AND THAT THE PHYSICIAN DID NOT KNOW THE REASON FOR THE PUMP FLIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14750769 ↗InjuryJun 1, 2022Battery Problem; Battery Problem
CLINICAL SPECIALIST (CS) REPORTED A PUMP REPLACEMENT WAS PERFORMED DUE TO THE DEVICE BEING AT THE END OF ITS LIFE AND HAD LOW BATTERY. THE REPLACED PUMP WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14570505 ↗InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PHYSICIAN CONTACTED TECHNICAL SOLUTIONS ABOUT A PATIENT THAT PRESENTED TO THE EMERGENCY ROOM WITH SIGNS OF AN OVERDOSE: PINPOINT EYES, LOSS OF COORDINATION, AND MORE. TECHNICAL SOLUTIONS WALKED THE PHYSICIAN THROUGH A DRAIN OF THE RESERVOIR WHICH WOULD EFFECTIVELY TURN THE PUMP OFF. TECHNICAL SOLUTIONS REFERRED THE EMERGENCY ROOM PHYSICIAN TO THE PATIENT'S MANAGING PHYSICIAN. REPORTING PHYSICIAN STATED THAT THE PATIENT IS STILL BEING EVALUATED, BUT THEY BELIEVED THAT A CHANGE IN THE PATIENT'S DOSING REGIMEN IS WHAT LED TO THE PATIENT SYMPTOMS. ADDITIONAL COMMUNICATION WITH NURSE FROM THE MANAGING PHYSICIAN'S OFFICE CONFIRMED THAT THE PATIENT'S PUMP WAS EMPTIED AND FILLED WITH SALINE. THE CAUSE OF THE PATIENT'S OVERDOSE SYMPTOMS IS UNKNOWN. THE PATIENT'S DOSAGE HAD NOT BEEN RECENTLY CHANGED AS THE LAST CHANGE WAS A YEAR AGO. THE PATIENT WAS SCHEDULED FOR A PUMP REFILL TWO AND A HALF WEEKS AGO, BUT CANCELLED THEIR APPOINTMENT. PHYSICIAN'S ASSISTANT FROM HOSPITAL ALSO COMMUNICATED TO THE OFFICE THAT PATIENT WISHES TO HAVE PUMP REMOVED. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: Movement Disorder; Unspecified Eye / Vision Problem
MAUDE report 14523005 ↗InjuryMay 18, 2022Communication or Transmission Problem; Communication or Transmission Problem
CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT A PATIENT'S PUMP THAT WAS NOT COMMUNICATING WITH THE CLINICIAN PROGRAMMER. THERE WERE NO VOLUME DISCREPANCIES ALLEGED AND NO PATIENT SYMPTOMS ALLEGED EITHER. THE PHYSICIAN WAS ABLE TO ACCESS THE PUMP AND REFILL THE PUMP, BUT CANNOT CHANGE ANY OF THE PROGRAMMING PARAMETERS. DIRECTOR OF CLINICAL ENGINEERING ATTEMPTED SEVERAL TIMES WITH DIFFERENT PROGRAMMERS TO COMMUNICATE WITH THE PUMP, BUT WAS UNSUCCESSFUL. THE PUMP WAS LATER EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14428713 ↗InjuryMay 12, 2022Use of Device Problem; Use of Device Problem
OFFICE MANAGER OF PHYSICIAN'S OFFICE CONTACTED TECHNICAL SOLUTIONS TO REPORT A PATIENT'S ADVERSE REACTIONS AFTER A REFILL PROCEDURE. DURING THE CALL, TECHNICAL SOLUTIONS DETERMINED THAT DURING THE REFILL, ONLY 9ML OF THE 20ML WAS ABLE TO BE PULLED BACK WHEN THE VOLUME CHECK WAS PERFORMED. BASED ON THIS INFORMATION, THIS ISSUE IS BELIEVED TO A POCKET FILL RATHER THAN A PUMP MALFUNCTION. NARCAN WAS ADMINISTERED TO THE PATIENT AND THEY WERE TAKEN TO THE HOSPITAL. OFFICE MANAGER REPORTED THAT THE PATIENT IS DOING FINE NOW.
Patient problems: Insufficient Information
MAUDE report 14380172 ↗InjuryApr 20, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
AGENT CONTACTED TECHNICAL SOLUTIONS TO REPORT A PUMP REPLACEMENT DUE TO UNDER INFUSION VOLUME DISCREPANCY. FOR THE FIRST ALLEGED VOLUME DISCREPANCY, THE EXPECTED VOLUME WAS 4ML AND THE ACTUAL ASPIRATED VOLUME WAS 12ML. A WEEK LATER, ANOTHER UNDER INFUSION WAS OBSERVED WITH THE EXPECTED VOLUME BEING 3.2ML AND THE ACTUAL ASPIRATED VOLUME BEING 12ML. A DYE STUDY WAS PERFORMED ON THIS DAY, CONFIRMING THAT THE CATHETER WAS PATENT. THE NEXT DAY, THE PATIENT HAD REPORTED EXPERIENCING CHILLS AND WITHDRAWAL SYMPTOMS. THE PHYSICIAN DECIDED TO REPLACE THE PATIENT'S PUMP.
Patient problems: Chills; Discomfort
MAUDE report 14163691 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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