Prometra Patient Therapy Controller 12860Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00810335020174), received between Nov 5, 2015 and Dec 6, 2019 — classified as 3 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (32 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2019Excess Flow or Over-Infusion; Adverse Event Without Identified Device or Use Problem; Excess Flow or Over-Infusion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE ERROR CODE 38S AND POTENTIAL OVER DELIVERY OF MEDICATION. PATIENT REPORTS WITHDRAWAL SYMPTOMS - SWEATING, NAUSEA AND VOMITING.

  Patient problems: Nausea; Patient Problem/Medical Problem

  MAUDE report 9433081 ↗
• InjuryOct 13, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL. THE PATIENT HAD ONLY VISITED THE EMERGENCY ROOM AND WAS LATER RELEASED. NO ADDITIONAL ISSUES WERE REPORTED.

  Patient problems: Patient Problem/Medical Problem; Vomiting

  MAUDE report 6949858 ↗
• MalfunctionDec 15, 2016Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT A BUTTON ON THE PATIENT THERAPY CONTROLLER (PTC) IS NOT RESPONSIVE UNLESS THE DEVICE IS PLUGGED INTO A WALL CHARGER AND UNPLUGGED. THERE WERE NO PATIENT EFFECTS REPORTED, AND THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6179433 ↗
• MalfunctionDec 15, 2016Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) WOULD NOT TURN ON. THERE WERE NO PATIENT EFFECTS REPORTED, AND THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6179315 ↗
• MalfunctionDec 15, 2016Device Issue; Device Issue

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) BATTERY DEPLETED QUICKLY, AND THAT THE PRESCRIPTION INFORMATION ON THE PTC WAS ERASED TWICE. THE PATIENT REPORTED EXPERIENCING INCREASED PAIN. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 6179242 ↗
• MalfunctionDec 9, 2016Device Issue; Device Issue

  IT WAS REPORTED THE PATIENT THERAPY CONTROLLER (PTC) WAS INCONSISTENT IN BOLUS DELIVERY, AND DISPLAYED BATTERY CHARGING ISSUES. THERE WERE NO PATIENT EFFECTS REPORTED, AND THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6157812 ↗
• MalfunctionDec 2, 2016Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) WAS RECONFIGURED DURING AN APPOINTMENT. AFTER THE RECONFIGURATION WAS COMPLETE, THE PTC DISPLAYED A MESSAGE INDICATING THAT THE DEVICE MUST BE CONFIGURED BEFORE USE MULTIPLE TIMES OVER A THREE WEEK PERIOD. THERE WERE NO PATIENT EFFECTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6142614 ↗
• MalfunctionDec 2, 2016Crack; Device Operational Issue; Crack; Device Operational Issue

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) WAS DROPPED, WHICH CAUSED THE SCREEN TO CRACK. THE DEVICE SUBSEQUENTLY COULD NOT BE POWERED ON. THERE WERE NO PATIENT EFFECTS REPORTED, AND THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6142611 ↗
• MalfunctionDec 2, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) DISPLAYED BATTERY CHARGING AND BOLUS DELIVERY ISSUES. THERE WERE NO PATIENT EFFECTS REPORTED, AND THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6142603 ↗
• MalfunctionNov 23, 2016Device Issue; Device Issue

  IT WAS REPORTED THE PATIENT THERAPY CONTROLLER (PTC) WAS INCONSISTENT IN BOLUS DELIVERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6125414 ↗
• MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) COULD NOT BE POWERED ON, BUT DISPLAYED THAT IT WAS FULLY CHARGED WHEN CONNECTED TO THE CHARGER. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6125399 ↗
• MalfunctionNov 9, 2016Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) BECAME UNRESPONSIVE. TROUBLESHOOTING ATTEMPTS WERE NOT SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6091060 ↗
• MalfunctionNov 9, 2016Crack; Device Operational Issue; Crack; Device Operational Issue

  IT WAS REPORTED THAT THE TOUCHSCREEN ON THE PATIENT THERAPY CONTROLLER (PTC) WAS NOT FUNCTIONAL, AND THAT THE SCREEN HAS A HAIRLINE CRACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6091059 ↗
• MalfunctionNov 2, 2016Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) POWER BUTTON IS WORN AND DIFFICULT TO USE. THERE WERE NO PATIENT EFFECTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6074502 ↗
• MalfunctionNov 2, 2016Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) BECAME UNRESPONSIVE. TROUBLESHOOTING ATTEMPTS WERE NOT SUCCESSFUL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6074486 ↗
• MalfunctionOct 19, 2016Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT THE BUTTONS ON THE PATIENT THERAPY CONTROLLER (PTC) WERE DAMAGED. THE DEVICE WAS UNRESPONSIVE WHEN CHARGED OR WHEN A BUTTON WAS PUSHED. THE PATIENT REPORTED THAT THERE WAS NO PHYSICAL DAMAGE. THE PATIENT REPORTED THAT SHE EXPERIENCED A DECREASE IN PAIN RELIEF. THE MANAGING INFUSION NURSE LATER REPORTED THAT THE BUTTON ISSUE DID NOT APPEAR TO BE DUE TO WEAR AND TEAR DUE TO NORMAL USAGE, AND THAT IT IS POSSIBLE THE DEVICE WAS DAMAGED IN SOME WAY.

  Patient problems: Pain

  MAUDE report 6039656 ↗
• MalfunctionOct 19, 2016Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) BECAME UNRESPONSIVE. TROUBLESHOOTING ATTEMPTS WERE NOT SUCCESSFUL. THERE WERE NO PATIENT EFFECTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6039655 ↗
• MalfunctionOct 12, 2016Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A BUTTON ON THE PATIENT THERAPY CONTROLLER (PTC) WAS DAMAGED FROM USE. THERE WERE NO PATIENT EFFECTS REPORTED. THE DEVICE IS FUNCTIONAL AND WILL NOT BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6023949 ↗
• MalfunctionOct 6, 2016Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER WAS RECONFIGURED DURING AN APPOINTMENT. AFTER THE RECONFIGURATION WAS COMPLETE, THE PTC WAS REMOVED FROM THE CHARGER. THE PTC THEN DISPLAYED A MESSAGE INDICATING THAT THE DEVICE MUST BE CONFIGURED BEFORE USE. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS RESOLVED. THERE WERE NO PATIENT EFFECTS REPORTED, AND THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 6003165 ↗
• MalfunctionSep 30, 2016Display or Visual Feedback Problem; Device Displays Incorrect Message; Device Operational Issue; Display or Visual Feedback Problem; Device Displays Incorrect Message; Device Operational Issue

  AFTER A REFILL APPOINTMENT ON (B)(6) 2016, IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) DISPLAYED AN ERROR MESSAGE INDICATING THAT A PHYSICIAN MUST CONFIGURE THE DEVICE BEFORE USE. THE DEVICE WAS RECONFIGURED ON (B)(6) 2016. DURING THE RECONFIGURATION APPOINTMENT, AN ERROR CODE WAS DISPLAYED WHEN THE PATIENT INITIALLY ATTEMPTED TO DELIVER A BOLUS WITH THE PTC. THE SECOND ATTEMPT WAS SUCCESSFUL. WHEN THIS BOLUS WAS BEING DELIVERED, THE PTC INCORRECTLY DISPLAYED THAT THE NEXT BOLUS WILL BE AVAILABLE IN 20 MINUTES, WHEN IT SHOULD HAVE BEEN 4 HOURS AND 20 MINUTES. THE PATIENT BOLUSED THEMSELVES AGAIN ONCE THE 20 MINUTE PERIOD WAS COMPLETE. THE PTC THEN DISPLAYED THE CORRECT PERIOD OF 4 HOURS AND 20 MINUTES FOR THE NEXT BOLUS. IT WAS LATER REPORTED THAT THE PATIENT WAS ABLE TO GIVE THEMSELVES MORE BOLUS THAN ALLOTTED WITHIN A 24 HOUR PERIOD. THERE WERE NO PATIENT EFFECTS REPORTED. NO FURTHER ISSUES WERE REPORTED, AND THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5990253 ↗
• MalfunctionSep 29, 2016Device Issue; Device Issue

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) MAY HAVE BEEN DAMAGED DURING A TORNADO, AND THAT THE REFILL DATES FREQUENTLY CHANGED AFTER THE TORNADO. THE PATIENT NOTED THAT SHE WAS NOT RECEIVING ADEQUATE PAIN RELIEF. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 5988835 ↗
• MalfunctionSep 29, 2016Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A BUTTON ON THE PATIENT THERAPY CONTROLLER (PTC) WAS DAMAGED FROM USE. THERE WERE NO PATIENT EFFECTS REPORTED, AND THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5988825 ↗
• MalfunctionSep 21, 2016Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING INITIAL SETUP, THE PATIENT THERAPY CONTROLLER (PTC) WAS ABLE TO SCAN AND CONNECT TO A PROGRAMMER WHILE CHARGING. UPON UNPLUGGING THE PTC FROM THE CHARGER, THE PTC SCREEN WENT BLACK AND BECAME UNRESPONSIVE. TROUBLESHOOTING ATTEMPTS WERE NOT SUCCESSFUL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5967613 ↗
• MalfunctionSep 21, 2016Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING INITIAL SETUP, THE PATIENT THERAPY CONTROLLER (PTC) WAS ABLE TO SCAN AND CONNECT TO A PROGRAMMER WHILE CHARGING. UPON UNPLUGGING THE PTC FROM THE CHARGER, THE PTC SCREEN WENT BLACK AND BECAME UNRESPONSIVE. TROUBLESHOOTING ATTEMPTS WERE NOT SUCCESSFUL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5967591 ↗
• MalfunctionSep 21, 2016Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) WAS RECONFIGURED DURING AN APPOINTMENT. AFTER THE RECONFIGURATION WAS COMPLETE, THE PTC WAS REMOVED FROM THE CHARGER. THE PTC THEN DISPLAYED A MESSAGE INDICATING THAT THE DEVICE MUST BE CONFIGURED BEFORE USE. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS RESOLVED. THERE WERE NO PATIENT EFFECTS REPORTED, AND THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5967585 ↗

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-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-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-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-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-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-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-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-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