Prometra Programmable Pump 11827Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00810335020082), received between Aug 13, 2015 and Jun 6, 2023 — classified as 9 deaths, 59 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (19 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

Recent adverse event reports

The 25 most recent of 83 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL SPECIALIST (CS) REPORTED THAT A PHYSICIAN TOLD THEM THAT A PATIENT HAD SYMPTOMS OF BEING POSSIBLY OVER-INFUSED FOLLOWING AN MRI THAT WAS DONE THE PREVIOUS WEEK. THE PATIENT'S MEDICATION DOSE WAS SUBSEQUENTLY DECREASED. CS STATED THAT THEY HAD COVERED THE MRI APPOINTMENT AND ALL PROPER STEPS WERE FOLLOWED. IT IS UNKNOWN WHAT CAUSED THE ISSUE TO OCCUR.

  Patient problems: Insufficient Information; Lethargy

  MAUDE report 13172215 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT A PUMP EXPLANT. ADDITIONAL COMMUNICATION WITH A REPRESENTATIVE FROM THE PHYSICIAN'S OFFICE CONFIRMED THAT THE PHYSICIAN MENTIONED THAT THE PATIENT " WAS NOT GETTING THE MEDICATION" AND THAT THE PATIENT WANTED TO KEEP THE PUMP. THERE WAS NO INFORMATION PROVIDED OR AVAILABLE REGARDING VOLUME DISCREPANCIES, OTHER DIAGNOSTIC STUDIES, OR ANY OTHER SPECIFIC DETAILS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12192966 ↗
• InjuryJun 23, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CLINICAL SPECIALIST (CS) STATED THAT THEY HAD SPOKE TO THE ATTENDING PHYSICIAN AND CONFIRMED THAT THE PATIENT IS RESPONSIVE AND AWAKE. IT WAS ALSO STATED THAT THE PATIENT HAS A TRACH, AND IF PLUGGED, CAN SOMEWHAT START VERBALIZING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Convulsion/Seizure

  MAUDE report 12053780 ↗
• InjuryJun 15, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AGENT CONTACTED TECHNICAL SOLUTIONS TO REPORT A PUMP REPLACEMENT DUE TO UNDERINFUSION VOLUME DISCREPANCIES AND UNRELIEVED PAIN. FOR THE FIRST UNDERINFUSION THAT WAS OBSERVED, THE EXPECTED VOLUME WAS 3.621ML AND THE ACTUAL ASPIRATED VOLUME WAS 6.4ML. THREE MONTHS LATER, THE PATIENT ENCOUNTERED A SECOND UNDERINFUSION VOLUME DISCREPANCY. THE EXPECTED VOLUME WAS 3.539ML AND THE ACTUAL ASPIRATED VOLUME WAS 18ML. A CATHETER DYE STUDY WAS PERFORMED THAT REVEALED NO PROBLEMS WITH THE PATIENT'S CATHETER.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12001508 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT TRACKING CONTACTED TECHNICAL SOLUTIONS IN ORDER TO REPORT A PROMETRA PUMP REPLACEMENT. IT WAS REPORTED THAT THE PATIENT WAS HAVING SYMPTOMS SUCH AS INSOMNIA AND INCREASED SPASTICITY. A SIDE PORT STUDY AS WELL AS A VALVE AND RESERVOIR CHECK WERE PERFORMED. ALL SHOWED THE PUMP AND CATHETER WERE FUNCTIONING PROPERLY. IT WAS STATED THAT THE PATIENT'S MEDICATION COULD HAVE BEEN WHAT WAS CAUSING THE SYMPTOMS. SYMPTOMS PERSISTED, AND THE PUMP WAS REPLACED TO ELIMINATE THE POSSIBILITY OF IT BEING THE CAUSE.

  Patient problems: Cramp(s) /Muscle Spasm(s); Muscle Spasm(s); Sleep Dysfunction

  MAUDE report 10477328 ↗
• InjuryMar 23, 2020Insufficient Flow or Under Infusion; Adverse Event Without Identified Device or Use Problem; Insufficient Flow or Under Infusion; Adverse Event Without Identified Device or Use Problem

  SALES REPRESENTATIVE REPORTED A PROMETRA PUMP EXPLANT DUE TO UNDERINFUSIONS. REPRESENTATIVE REPORTED THERE WERE MULTIPLE UNDERINFUSIONS OBSERVED, DATES AND VOLUMES UNKNOWN. REPRESENTATIVE REPORTED A CAP STUDY WAS PERFORMED AND RESULTS SHOWED A PATENT CATHETER. THE PROMETRA PUMP WAS EXPLANTED AND REPLACED WITH A PROMETRA II PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 9866321 ↗
• InjuryJan 13, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT ON (B)(6) 2019 PROMETRA 20 ML PUMP WAS EXPLANTED DUE TO VOLUME DISCREPANCIES. THE PATIENT EXHIBITED WITHDRAWAL SYMPTOMS. IT WAS REPORTED THAT THE PHYSICIAN REQUESTED AN EXPLANT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9583411 ↗
• InjuryDec 18, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  DURING THE FOLLOW-UP IT WAS INFORMED THAT THE PATIENT WAS IMPLANTED WITH A NEW FLOWONIX PUMP AND PATIENT'S SYMPTOMS HAVE RESOLVED. THEY ARE NOT EXPERIENCING ANY ISSUES WITH NEW PUMP. PATIENT'S PAIN IS MANAGED WITH THE NEW PUMP.

  Patient problems: Dizziness; Nausea; Patient Problem/Medical Problem

  MAUDE report 9490998 ↗
• InjuryDec 5, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  REPRESENTATIVE CONTACTED TECHNICAL SOLUTIONS TO REPORT UNDERINFUSION VOLUME DISCREPANCIES. FOR THE FIRST VOLUME DISCREPANCY, THE EXPECTED VOLUME WAS 6ML AND THE ACTUAL ASPIRATED VOLUME WAS 16ML. A FEW DAYS LATER, A CAP STUDY WAS PERFORMED. THE FIRST TIME THEY ATTEMPTED TO PUSH DYE INTO THE CAP NOTHING WAS SEEN AT THE CATHETER TIP SO THEY ATTEMPTED TO PUSH AGAIN AND DYE WAS SEEN EXITING THE CATHETER TIP. OVER A MONTH LATER, AN ADDITIONAL VOLUME DISCREPANCY WAS ALLEGED WITH THE EXPECTED VOLUME BEING 6.825ML AND THE ACTUAL ASPIRATED VOLUME BEING 18.5ML. IT WAS ADDITIONALLY CONFIRMED THAT THE PATIENT WAS NOT RECEIVING PAIN RELIEF. THE PUMP WAS LATER EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9419439 ↗
• InjuryJul 10, 2019Insufficient Flow or Under Infusion; No Flow; Insufficient Flow or Under Infusion; No Flow

  SALES REPRESENTATIVE CONTACTED TECHNICAL SOLUTIONS TO REPORT A PATIENT'S PUMP THAT WAS EXPLANTED. REPRESENTATIVE STATED THAT INITIALLY AN UNDERINFUSION VOLUME DISCREPANCY WAS OBSERVED, WITH AN EXPECTED VOLUME OF 14.5ML AND AN ACTUAL ASPIRATED VOLUME WAS 17ML. REPRESENTATIVE REPORTED THAT THE BATTERY LEVEL WAS "OK" AND THAT THERE WERE NO ERROR MESSAGES. WHEN THE PHYSICIAN ADDITIONALLY DISCONNECTED THE PUMP FROM THE CATHETER THERE WAS SIGNIFICANT CSF BACK-FLOW. THE PHYSICIAN THEN MANUALLY PUSHED SALINE THROUGH THE CAP PORT THEN DECIDED TO PUT SALINE INTO THE RESERVOIR TO RUN THE BOLUS. TECHNICAL SOLUTIONS INSTRUCTED THE REPRESENTATIVE TO PROGRAM A PUMP PRIME WHEN THE CATHETER WAS DISCONNECTED FROM THE PUMP, AND THE DOCTOR SAW ONE SMALL BEAD FORM AT THE END, BUT IT DID NOT DRIP. THE PHYSICIAN DETERMINED THAT THE PUMP SHOULD BE REPLACED SINCE THERE WAS MEDICATION ALREADY IN THE PDS WHICH SHOULD HAVE PUSHED ADDITIONAL VOLUME OUT OF THE STEM. HOWEVER, THE PUMP WAS NOT WARMED WHEN IT WAS PRIMED/DISCONNECTED FROM THE PUMP.

  Patient problems: Inadequate Pain Relief; Patient Problem/Medical Problem

  MAUDE report 8778060 ↗
• InjuryMay 13, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE VOLUME OF UNDELIVERED DRUG REMAINING IN THE DRUG RESERVOIR WAS GREATER THAN THE EXPECTED VOLUME BASED UPON THE PROGRAMMED INFUSION RATE. THE PUMP WAS SUBSEQUENTLY EXPLANTED.

  Patient problems: Pain

  MAUDE report 8605898 ↗
• InjuryMay 3, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE VOLUME OF UNDELIVERED DRUG REMAINING IN THE DRUG RESERVOIR WAS GREATER THAN THE EXPECTED VOLUME BASED UPON THE PROGRAMMED INFUSION RATE. THE PUMP WAS SUBSEQUENTLY EXPLANTED.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 8579244 ↗
• InjuryMar 12, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE VOLUME OF UNDELIVERED DRUG REMAINING IN THE DRUG RESERVOIR WAS GREATER THAN THE EXPECTED VOLUME BASED UPON THE PROGRAMMED INFUSION RATE. THE PUMP WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8414202 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S PUMP WAS EXPLANTED. THE REASON FOR THE EXPLANT IS CURRENTLY UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8140444 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S PUMP WAS EXPLANTED. THE REASON FOR THE EXPLANT IS CURRENTLY UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8140443 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S PUMP WAS EXPLANTED. THE REASON FOR THE EXPLANT IS CURRENTLY UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8140438 ↗
• InjuryDec 6, 2018Insufficient Flow or Under Infusion; Insufficient Device Problem Information; Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S PUMP WAS EXPLANTED. THE REASON FOR THE EXPLANT IS CURRENTLY UNKNOWN.

  Patient problems: No Code Available; Pain; Patient Problem/Medical Problem

  MAUDE report 8140433 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S PUMP WAS EXPLANTED. THE REASON FOR THE EXPLANT IS CURRENTLY UNKNOWN.

  Patient problems: No Code Available; Pressure Sore/Ulcer

  MAUDE report 8140430 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S PUMP WAS EXPLANTED. THE REASON FOR THE EXPLANT IS CURRENTLY UNKNOWN.

  Patient problems: No Code Available; Seroma

  MAUDE report 8140422 ↗

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