Infinity Orange Enteral Feeding Pump INFORNGRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10814844000334), received between May 6, 2024 and Jul 27, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (15 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, 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50007978 ↗
• MalfunctionMay 18, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS OVER INFUSING AND DID NOT STOP WHEN THE FOOD RAN OUT, THAT IT WAS PUMPING AIR. MMD DID FOLLOW UP WITH THE INITIAL REPORTER WHO STATED THAT THE PATIENT HAD NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THE COMPLAINT. NO ADDITIONAL INFORMATION WAS PROVIDED. [COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204471 ↗
• MalfunctionMay 18, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS NOT ALARMING NO FLOW OUT WHEN FOOD WAS NOT BEING DELIVERED. MMD DID NOT FOLLOW UP WITH THE INITIAL REPORTER BECAUSE AT THE TIME OF THE COMPLAINT THEY STATED THAT THE COMPLAINT OCCURRED DURING TESTING AND HAD NO EFFECT ON A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. [COMPLAINT(B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204470 ↗
• MalfunctionSep 2, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP DID NOT ALARM AS EXPECTED. THEY STATED THAT IT DID NOT ALARM AUDIBLY AT ALL. MMD DID FOLLOW UP WITH THE INITIAL REPORTER WHO STATED THAT THAT THE COMPLAINT HAD OCCURRED DURING TESTING AND DID NOT AFFECT A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. [(B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946982 ↗
• MalfunctionJul 10, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP HAD BROKEN HINGES AND A CRACKED DOOR LATCH. WHEN THE PUMP WAS RETURNED TO MMD FOR EVALUATION, THE NO FLOW OUT ALARM DID NOT OPERATE AS EXPECTED. IT FAILED TO ALARM. THE INITIAL REPORTER STATED THAT THE COMPLAINT HAD OCCURRED DURING TESTING AND HAD NOT HAD ANY ADVERSE EFFECT ON A PATIENT. THE ALARM FAILURE WAS DISCOVERED AT MOOG. [(B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470799 ↗
• MalfunctionMar 11, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP HAD DAMAGE TO THE HINGES, DOOR LATCH, AND KEYPAD. WHEN THE PUMP WAS RETURNED TO MMD FOR EVALUATION, THE NO FLOW OUT ALARM DID NOT ALARM AS EXPECTED. IT FAILED TO ALARM. THE INITIAL REPORTER STATED THAT THE COMPLAINT HAD OCCURRED DURING TESTING AND HAD NOT HAD ANY ADVERSE EFFECT ON A PATIENT. THE ALARM FAILURE WAS DISCOVERED AT MOOG. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575434 ↗
• MalfunctionMar 7, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS NOT ALARMING NO FLOW OUT AS EXPECTED. THEY STATED IT FAILED TO ALARM. MMD DID FOLLOW UP WITH THE INITIAL REPORTER WHO STATED THAT THE COMPLAINT HAD OCCURRED DURING TESTING AND HAD NO EFFECT ON A PATIENT. THEY STATED THAT THEY DID NOT HAVE ANY ADDITIONAL INFORMATION. COMPLAINT-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549377 ↗
• MalfunctionFeb 7, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS NOT ALARMING NO FLOW OUT AS EXPECTED. THEY STATED IT FAILED TO ALARM. MMD DID FOLLOW UP WITH THE INITIAL REPORTER WHO STATED THAT THE COMPLAINT HAD OCCURRED DURING TESTING AND HAD NO EFFECT ON A PATIENT. THEY STATED THAT THEY DID NOT HAVE ANY ADDITIONAL INFORMATION. [COMPLAINT: (B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21336335 ↗
• MalfunctionJan 20, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP FRONT HOUSING, HINGES AND KEYPAD WERE DAMAGED. WHEN THE PUMP WAS RETURNED TO MMD FOR EVALUATION, THE SHUT DOOR AND LOAD SET ALARMS DID NOT ALARM AS EXPECTED. THEY FAILED TO ALARM. THE INITIAL REPORTER STATED THAT THE COMPLAINT HAD OCCURRED DURING TESTING AND HAD NOT HAD ANY ADVERSE EFFECT ON A PATIENT. THE ALARM FAILURE WAS DISCOVERED AT MOOG. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21192718 ↗
• MalfunctionDec 9, 2024Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS ALARMING, BUT THAT THEY COULD NOT READ ANYTHING ON THE SCREEN. THEY STATED THAT FORMULA HAD BEEN SPILLED ON THE PUMP, AND THEY COULD SEE IT INSIDE THE PUMP SCREEN. THEY STATED THAT THIS RESULTED IN A SIX HOUR DELAY OF THERAPY AND THAT THEY WERE NOT ABLE TO COMPLETE THE FEEDING VIA GRAVITY BECAUSE THE PATIENT DID NOT TOLERATE IT. MMD DID FOLLOW UP WITH THE INITIAL REPORTER, WHO STATED THAT THE PATIENT DID NOT HAVE ANY ADVERSE EFFECTS DUE TO THE COMPLAINT, THAT THE PUMP HAD BEEN REPLACED, THAT THEY COULD NOT PROVIDE THE PUMP SERIAL NUMBER, AND HAD NO OTHER INFORMATION TO PROVIDE. [ (B)(6) ].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20884473 ↗
• MalfunctionOct 10, 2024Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP DID NOT ALARM NO FLOW OUT AS EXPECTED. THEY STATED THE PUMP FAILED TO ALARM. MMDG DID FOLLOW UP WITH THE INITIAL REPORTER WHO STATED THAT THEY HAD NO FURTHER INFORMATION ABOUT THE COMPLAINT. THEY REPORTED THAT THE COMPLAINT OCCURRED DURING TESTING AND NO PATIENT HAD BEEN INVOLVED. [ (B)(4) ].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417767 ↗
• MalfunctionSep 17, 2024Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS PUMPING AFTER FOOD WAS GONE AND DID NOT ALARM. THEY STATED THAT THEY DID NOT HAVE ANY INFORMATION ABOUT THE PUMP SETTINGS. AT THE TIME OF THE COMPLAINT THE INITIAL REPORTER STATED THAT THEY DID NOT HAVE ANY ADDITIONAL INFORMATION ABOUT THE COMPLAINT BECAUSE IT WAS NOT AVAILABLE. THEY DID STATE THAT THERE HAD BEEN NO ADVERSE EFFECTS TO THE PATIENT. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238767 ↗
• MalfunctionJul 1, 2024Failure to Deliver; Failure to Deliver

  THE INITIAL REPORTER STATED THAT THE PUMP WAS NOT DELIVERING FORMULA DURING THE PATIENTS FEEDING. MMDG DID FOLLOW UP WITH THE INITIAL REPORTER WHO STATED THAT THE PUMP DID NOT ALARM. THEY STATED THAT THE PATIENT HAD NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THE COMPLAINT. NO OTHER INFORMATION WAS PROVIDED. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651798 ↗
• MalfunctionJun 27, 2024Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP HAD CRACKED HINGES. WHEN THE PUMP WAS RETURNED TO MMDG FOR EVALUATION, THE NO FLOW OUT ALARM DID NOT ALARM AS EXPECTED. IT FAILED TO ALARM. THE INITIAL REPORTER STATED THAT THE COMPLAINT HAD NOT HAD ANY ADVERSE EFFECT ON A PATIENT. THE ALARM FAILURE WAS DISCOVERED AT MOOG. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19628094 ↗
• MalfunctionMay 22, 2024Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WOULD NOT PRIME AND THAT AND THAT IT WOULD NOT DELIVER BUT DID APPEAR TO BE RUNNING. THEY DID ATTEMPT SOME TROUBLESHOOTING WITH A NEW SET AND WATER AND THEY WERE UNABLE TO CORRECT THE ISSUE. MMDG DID FOLLOW UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL COMPLAINT INFORMATION. THEY DID NOT REPORT ANY ADVERSE EFFECT TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375460 ↗
• MalfunctionMay 6, 2024Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS NOT ALARMING LOAD SET AS EXPECTED. THEY STATED THAT IT FAILED TO ALARM. AT THE TIME OF THE COMPLAINT, THE INITIAL REPORTER STATED THAT THE COMPLAINT OCCURRED DURING TESTING AND HAD NO EFFECT ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED. [(B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249566 ↗