Prometra Catheter Revision Kit 11830Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00810335020105), received between May 26, 2017 and Oct 10, 2023 — classified as 40 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2023Obstruction of Flow; Obstruction of Flow

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL WHICH REPORTED A CATHETER REPLACEMENT DUE TO THE ORIGINAL CATHETER BECOMING OCCLUDED. THE ORIGINAL CATHETER WAS DISCARDED AFTER THE REPLACEMENT SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906019 ↗
• InjuryFeb 17, 2023Migration; Migration

  REPORTER INITIALLY CONTACTED TECHNICAL SOLUTIONS TO INQUIRE ABOUT HOW TO TURN A PATIENT'S PUMP OFF. REPORTER STATED THAT THE PATIENT HAS SALINE IN THEIR PUMP AT A MINIMAL FLOW RATE AND IS CURRENTLY WAITING TO HAVE THEIR PUMP EXPLANTED. REPORTER STATED THAT THEY VISITED THE PATIENT FOR A REFILL APPROXIMATELY A YEAR AGO AND FOUND THAT THE PUMP WAS EMPTY WHEN IT WAS NOT EXPECTED TO BE. AT THAT TIME, THE PATIENT INFORMED THE REPORTER THAT THEY HAD FLU-LIKE SYMPTOMS FOR THE PREVIOUS 10 DAYS THAT RESULTED IN THEM GOING TO THE ER. THE HOSPITAL COULD NOT TEST FOR COVID AT THE TIME, BUT INFORMED THE PATIENT THAT THEY MOST LIKELY HAD COVID. THE REPORTER WENT ON TO EXPLAIN THAT, AFTER THIS INCIDENT, A DYE STUDY WAS PERFORMED WHICH SHOWED A LEAK. THE REPORTER DID NOT KNOW ANY MORE INFORMATION. LATER COMMUNICATION WITH THE REPORTER CONFIRMED THAT THE DYE STUDY DID NOT SHOW A LEAK, BUT INSTEAD SHOWED THAT THE CATHETER HAD MIGRATED OUT OF THE INTRATHECAL SPACE. THE PHYSICIAN DECIDED TO PERFORM A PUMP EXPLANT RATHER THAN A CATHETER REVISION BECAUSE THE PATIENT STATED THAT THEY NO LONGER WANTED TO USE THE PUMP. IT IS BELIEVED THAT THE CATHETER REMAINS IMPLANTED.

  Patient problems: Discomfort; Fatigue

  MAUDE report 16399507 ↗
• InjuryJan 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REVISION. THE REASON FOR REVISION WAS CONFIRMED TO BE A TEAR IN THE CATHETER. ADDITIONAL COMMUNICATION WITH THE REPRESENTATIVE COVERING THE ISSUE CONFIRMED THAT THERE WAS A SEROMA AT THE INCISION SITE WHICH LED THE PHYSICIAN TO REPLACE THE CATHETER.

  Patient problems: Seroma

  MAUDE report 16119053 ↗
• InjuryNov 23, 2022Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED REPORTING A SYSTEM REPLACEMENT DUE TO "CATHETER ISSUES" AND THE "PATIENT NEEDING A LARGER PUMP." SEVERAL ATTEMPTS WERE MADE TO FOLLOW UP WITH THE AGENT COVERING THE ISSUE, BUT NO INFORMATION HAS BEEN RECEIVED YET.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15854061 ↗
• InjuryOct 29, 2022Insufficient Flow or Under Infusion; Material Twisted/Bent; Migration; Insufficient Flow or Under Infusion; Material Twisted/Bent; Migration

  PATIENT TRACKING RECEIVED A TRACKING FORM IN THE MAIL REPORTING A CATHETER REVISION DUE TO A CATHETER KINK. LATER COMMUNICATION CONFIRMED THAT THE HEALTHCARE PROFESSIONAL REPORTED THAT A VOLUME DISCREPANCY OF 6.4ML WAS FOUND DURING THE LAST REFILL. PRIOR REFILLS WERE REPORTEDLY OFF BY 4-6ML, AND THE PATIENT HAD REPORTED AN INCREASE OF PAIN. DURING A DYE STUDY, MISPOSITIONING OF THE CATHETER WAS IDENTIFIED. THE CATHETER TIP WAS REPORTEDLY AT T11 IN THE FAR LATERAL RECESS. CAUSE OF THE MISPOSITIONING AND KINK WERE REPORTED TO BE UNKNOWN. CATHETER WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15695694 ↗
• InjuryOct 25, 2022Material Puncture/Hole; Material Puncture/Hole

  PATIENT TRACKING RECEIVED A TRACKING FORM REPORTING A CATHETER REVISION. TRACKING FORM STATED THAT THE REASON FOR REVISION WAS A LEAKING CATHETER THROUGH A HOLE WHERE THE CATHETER CONNECTS TO THE PUMP. THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667030 ↗
• InjuryJul 18, 2022No Flow; No Flow

  INFORMATION WAS RECEIVED THAT REPORTED A CATHETER REPLACEMENT. IT WAS REPORTED THAT THE PATIENT HAD BEEN IN THE HOSPITAL DUE TO COVID INFECTION ABOUT A YEAR AND A HALF AGO, WHICH CAUSED THEM TO MISS THEIR REFILL APPOINTMENT. THIS RESULTED IN THEIR PUMP RUNNING DRY AND HAVING WITHDRAWAL SYMPTOMS. AFTER ALL OF THEIR SUBSEQUENT REFILL APPOINTMENTS, THEY REQUESTED AN INCREASE AND STATED THAT THEIR PUMP WAS NOT HELPING ENOUGH. A CATHETER DYE STUDY WAS PERFORMED, WHICH STATED THAT THE CATHETER COULD NOT BE ASPIRATED. THE CATHETER WAS LATER REPLACED, AND THE REPLACED CATHETER WAS DISCARDED.

  Patient problems: Discomfort

  MAUDE report 15042281 ↗
• InjuryJun 29, 2022Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED REPORTING A CATHETER REPLACEMENT. THE PATIENT HAD COMPLAINED OF LACK OF PAIN RELIEF. THE PATIENT HAD A CAP STUDY PERFORMED WHERE THERE WAS NO ABILITY TO ASPIRATE THE CATHETER. DURING THE CATHETER SURGERY, IT WAS CONFIRMED THAT THE CATHETER WAS OCCLUDED DUE TO UNKNOWN REASONS. A NEW CATHETER WAS PLACED AND THE OLD CATHETER WAS TIED OFF, CLAMPED, AND LEFT IMPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14852025 ↗
• InjuryJun 7, 2022Material Twisted/Bent; Migration; Material Twisted/Bent; Migration

  INFORMATION WAS RECEIVED THAT REPORTED A CATHETER REPLACEMENT DUE TO MIGRATION AND KINK. PHYSICIAN STATED THAT THE CATHETER MIGRATED INITIALLY WHICH THEN CAUSED THE KINK. PHYSICIAN IS UNSURE WHAT CAUSED THE MIGRATION. THERE WERE NO VOLUME DISCREPANCIES IN THE LAST FEW PUMP REFILLS, BUT THE PATIENT COMPLAINED ABOUT INTERMITTENT FEELING OF WITHDRAWALS. A CATHETER DYE STUDY WAS PERFORMED, WHICH SHOWED THE MIGRATION OF THE CATHETER. THE CATHETER WAS DISCARDED.

  Patient problems: Discomfort

  MAUDE report 14619126 ↗
• InjuryJun 3, 2022Disconnection; Disconnection

  REPRESENTATIVE REPORTED A CATHETER REVISION. REPRESENTATIVE REPORTED THAT THE PATIENT ALLEGED A LACK OF PAIN RELIEF AND SWELLING IN THEIR PUMP POCKET. DURING THE REVISION SURGERY IT WAS CONFIRMED THAT THE CATHETER BECAME DISCONNECTED AT THE REVISION CONNECTION POINT.

  Patient problems: Inadequate Pain Relief; Swelling/ Edema

  MAUDE report 14596119 ↗
• InjuryApr 1, 2022Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED REPORTING A CATHETER REPLACEMENT. ADDITIONAL INFORMATION CONFIRMED THAT THERE WAS POSTURAL RESTRICTION ON THE CATHETER RESULTING IN A DECLINE IN PAIN RELIEF. THE CAUSE OF THE RESTRICTION WAS REPORTED TO BE UNKNOWN. THE REPLACED CATHETER WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13981368 ↗
• InjuryFeb 28, 2022Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  INFORMATION WAS RECEIVED THAT REPORTED THAT A PATIENT'S PUMP AND CATHETER WERE REPLACED. INITIALLY, THE PATIENT CALLED INTO THE PHYSICIAN'S OFFICE REQUESTING AN INCREASE IN DOSE DUE TO INCREASING PAIN OVER THE PREVIOUS TWO MONTHS. THE PATIENT DENIED ANY FALLS OR INJURIES. THE PATIENT WAS LATER SEEN FOR A SCHEDULED REFILL AND AN UNDERINFUSION VOLUME DISCREPANCY WAS OBSERVED. THE EXPECTED VOLUME WAS 4.519ML AND THE ACTUAL ASPIRATED VOLUME WAS 19ML. THE PATIENT BELIEVED THAT THEY COULD HAVE HAD WITHDRAWAL SYMPTOMS AS WELL. THE PATIENT LATER HAD AN EXPLANT PROCEDURE PERFORMED. DURING THE SURGERY, IT WAS OBSERVED THAT THE CATHETER WAS KINKED AND TWISTED IN THE PUMP POCKET. IT WAS REPORTED THAT THE PATIENT'S PUMP WAS REPLACED DUE TO THE PUMP'S AGE AND SINCE THE CATHETER WAS ALREADY BEING REPLACED. THE PHYSICIAN BELIEVES THAT THE ISSUES REPORTED FOR THIS PATIENT ARE RELATED TO THIS KINKED CATHETER, BUT THE CAUSE OF THE KINKING IS UNKNOWN.

  Patient problems: Discomfort; Inadequate Pain Relief

  MAUDE report 13618782 ↗
• InjuryFeb 9, 2022Obstruction of Flow; Obstruction of Flow

  CLINICAL SPECIALIST (CS) REPORTED THAT THE PATIENT HAD BEEN COMPLAINING OF INCREASED PAIN AND WITHDRAWAL-LIKE SYMPTOMS. CS REPORTED THAT THE PATIENT HAD A CATHETER DYE STUDY PERFORMED AND IT WAS NOTED THAT THE CATHETER WAS LIKELY OCCLUDED AND REQUIRED REPLACEMENT. IT WAS ALSO REPORTED THAT THERE HAD BEEN A GRADUAL INCREASE IN RESERVOIR VOLUME OVER THE PAST THREE REFILLS. THE PUMP AND CATHETER WERE REPLACED AND WERE DISCARDED. THE REPORTER WAS NOT INFORMED OF ANYTHING NOTED AT THE REPLACEMENT SURGERY. MDR 3010079947-2022-00012 WAS OPENED TO ADDRESS THE PUMP ISSUES.

  Patient problems: Discomfort; Inadequate Pain Relief

  MAUDE report 13497717 ↗
• InjuryNov 16, 2021Material Puncture/Hole; Material Puncture/Hole

  CLINICAL SPECIALIST (CS) REPORTED A CATHETER REVISION. IT WAS REPORTED THAT THE PATIENT HAD SWELLING AT THEIR PUMP POCKET. IT WAS BELIEVED THAT THE SWELLING WAS DUE TO A CSF LEAK. WHEN THE CATHETER WAS REVISED, IT WAS NOTED THAT IT LOOKED LIKE TWO AREAS OF THE CATHETER HAD BEEN RUBBING AGAINST EACH OTHER, CREATING A HOLE. THE REVISED SEGMENT OF CATHETER WAS DISCARDED.

  Patient problems: Cerebrospinal Fluid Leakage; Seroma

  MAUDE report 12820011 ↗
• InjuryNov 16, 2021Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT A PROMETRA II 20 ML PUMP WITH A VOLUME DISCREPANCY - UNDERINFUSION. THE EXPECTED VOLUME WAS 5.26ML AND THE ACTUAL ASPIRATED VOLUME WAS 18.7ML. CS REPORTED THAT THE PATIENT DID NOT REPORT ANY FALLS, TRAUMAS, OR MRIS. CS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF PAIN RELIEF. THIS WAS THE FIRST VOLUME DISCREPANCY FOR THE PATIENT. A CATHETER DYE STUDY WAS LATER PERFORMED AND THE PHYSICIAN WAS UNABLE TO ASPIRATE FROM THE CAP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12819849 ↗
• InjuryNov 11, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  A PHYSICIAN CONTACTED TECHNICAL SOLUTIONS TO REPORT A PATIENT WITH AN UNDERINFUSION VOLUME DISCREPANCY. THE EXPECTED VOLUME WAS 6ML AND THE ACTUAL ASPIRATED VOLUME WAS 20ML. PHYSICIAN REPORTED THAT THE PATIENT DID NOT HAVE ANY PUMP ERRORS WHEN THEY WERE LAST INQUIRED. THEY ALSO REPORTED THAT THE PATIENT HAD FALLEN SINCE THE TIME OF THEIR LAST REFILL. THE PATIENT REPORTED A COMPLETE LACK OF THERAPY. FOLLOW UP INFORMATION WAS PROVIDED BY THE CLINICAL SPECIALIST (CS) THAT CONFIRMED THAT A CAP STUDY WAS PERFORMED AND THE PHYSICIAN WAS UNABLE TO ASPIRATE. THE PHYSICIAN PLANNED ON DRAINING THE PUMP RESERVOIR AND LEAVING IT IDLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12795575 ↗
• InjuryAug 23, 2021Obstruction of Flow; Obstruction of Flow

  AGENT REPORTED A PUMP REPLACEMENT DUE TO PATIENT RECEIVING INCONSISTENT RELIEF. SIDE PORT STUDY WAS PERFORMED AND HAD INDICATED THAT THE CATHETER WAS WORKING FINE. DURING THE SURGERY, THE CATHETER WAS FOUND TO BE KINKED DUE TO SCAR TISSUE BEING WRAPPED AROUND THE CATHETER. PHYSICIAN REMOVED THE EXCESS SCAR TISSUE, AND THE CATHETER WAS FOUND TO HAVE GOOD FLOW. THERE WERE NO ISSUES WITH THE PUMP, ALTHOUGH PUMP WAS REPLACED DUE TO DEVICE AGE. PUMP WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12353729 ↗
• InjuryAug 11, 2021Fracture; Fracture

  CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT A CATHETER REVISION DUE TO CATHETER FRACTURE. THE PATIENT REPORTED A LACK OF PAIN RELIEF. THE REVISED SEGMENT OF CATHETER WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12306450 ↗
• InjuryAug 10, 2021Fracture; Insufficient Flow or Under Infusion; Material Twisted/Bent; Migration; Fracture; Insufficient Flow or Under Infusion; Material Twisted/Bent; Migration

  CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT A CATHETER REVISION. INITIALLY, THE PATIENT WAS SEEN FOR A REFILL APPOINTMENT WHERE THEY REPORTED UNRELIEVED PAIN. AN UNDERINFUSION VOLUME DISCREPANCY WAS OBSERVED WITH THE EXPECTED VOLUME BEING 0.0ML AND THE ACTUAL ASPIRATED VOLUME WAS 18.4ML. DAYS LATER, A CATHETER DYE STUDY WAS PERFORMED DURING WHICH THE PHYSICIAN WAS UNABLE TO ASPIRATE CSF. IT WAS OBSERVED THAT THE CATHETER TIP HAD MIGRATED OUT OF THE INTRATHECAL SPACE AND HAD KINKED. THE PATIENT'S CATHETER WAS LATER REVISED. DURING THE REVISION SURGERY, A CATHETER FRACTURE WAS OBSERVED. THE REMOVED CATHETER PORTION WAS DISCARDED. DURING THE SURGERY, THE PATIENT'S PUMP WAS REANCHORED AS WELL. PLEASE NOTE THAT MFR 3010079947-2021-00237 WILL CAPTURE THE PUMP REVISION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12302919 ↗
• InjuryJul 21, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  AGENT CONTACTED TECHNICAL SOLUTIONS TO REPORT A CATHETER REVISION DUE TO CATHETER FRACTURING. THE PATIENT REPORTED A LACK OF PAIN RELIEF.

  Patient problems: Inadequate Pain Relief; Seroma; Skin Inflammation/ Irritation

  MAUDE report 12202802 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS PROVIDED THAT REPORTED A CATHETER REVISION OCCURRED DUE TO THE CATHETER BEING EXPOSED. PATIENT INITIALLY PRESENTED WITH REDNESS AND LOW BACK PAIN. THE PATIENT HAD ABOUT TWO CENTIMETERS OF TISSUE REMOVED FROM THE CATHETER SITE AND NO DISCHARGE WAS NOTED. THE INCISION WAS THEN CLOSED. ADDITIONAL COMMUNICATION CONFIRMED THAT THE PATIENT'S CATHETER WAS REPLACED DUE TO THE TISSUE DEADENING AND WOUND DEHISCENCE, LEADING TO THE EXPOSURE. THE ORIGINAL CATHETER WAS DISCARDED AFTER THE REPLACEMENT SURGERY.

  Patient problems: Impaired Healing; Pain; Skin Inflammation/ Irritation; Wound Dehiscence

  MAUDE report 12127738 ↗
• InjuryJul 7, 2021Obstruction of Flow; Obstruction of Flow

  CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT A CATHETER REPLACEMENT. IT WAS REPORTED THAT THE PATIENT HAD INCREASED PAIN, AND A CATHETER DYE STUDY WAS SCHEDULED. DURING THE DYE STUDY, THE PHYSICIAN COULD NOT ASPIRATE FROM THE CAP. DURING THE SURGERY, THE PHYSICIAN SPLICED THE CATHETER AND THERE WAS NO CSF FLOW FROM THE SPINAL SEGMENT. THE CATHETER WAS REPLACED AND WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12127662 ↗
• InjuryJul 2, 2021Obstruction of Flow; Obstruction of Flow

  CLINICAL SPECIALIST (CS) REPORTED THAT A PATIENT FELT CONFUSION FOLLOWING PATIENT THERAPY CONTROLLER DOSES AFTER PUMP REFILLS. PATIENT REPORTEDLY HAS AN OLDER MEDTRONIC CATHETER CONNECTED TO A FLOWONIX CATHETER WHICH CONNECTS TO THE PUMP. PER FOLLOW-UP, NURSE PRACTIONER REPORTED A CATHETER DYE STUDY WAS PERFORMED TWO YEARS AGO IN WHICH THE CATHETER COULD NOT BE ASPIRATED. IT WAS BELIEVED THE POSSIBLE ISSUE COULD BE KINKING OF THE CATHETER, BUT THE EXACT REASON FOR CAP STUDY COULD NOT BE CONFIRMED. PATIENT IS CURRENTLY DOING WELL WITH NO FURTHER ISSUES REPORTED.

  Patient problems: Confusion/ Disorientation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12110112 ↗
• InjuryJul 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  REPORTER CONTACTED TECHNICAL SOLUTIONS TO REPORT THAT A CATHETER WAS REPLACED BECAUSE IT WAS TORN. THE CATHETER WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12107180 ↗
• InjuryJun 11, 2021Material Twisted/Bent; Material Twisted/Bent

  A PATIENT CONTACTED TECHNICAL SOLUTIONS TO REPORT THAT THEY HAD THEIR PUMP EXPLANTED ABOUT TWO YEARS AGO DUE TO A LACK OF PAIN RELIEF. PER THE PATIENT, THE SURGERY WAS INITIALLY PERFORMED TO REPLACE THE PUMP, BUT DURING THE SURGERY, IT WAS DISCOVERED THAT THE CATHETER WAS KINKED. PHYSICIAN REPLACED BOTH THE PUMP AND THE CATHETER, BUT ALLEGEDLY CONCLUDED THERE WAS NO ISSUE WITH THE PUMP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11986430 ↗

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-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-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-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-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-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-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-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