Infinity Orange Enteral Feeding Pump INFORNGRFRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10814844000341), received between Sep 25, 2024 and Dec 2, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS NOT DELIVERING FORMULA AND DID NOT ALARM NO FLOW OUT AS EXPECTED. THEY STATED IT FAILED TO ALARM. MMD DID FOLLOW UP WITH THE INITIAL REPORTER, AND THEY STATED THAT THE PATIENT HAD NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THE COMPLAINT. NO ADDITIONAL INFORMATION WAS PROVIDED. [(B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697828 ↗
• MalfunctionOct 16, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP HINGES WERE CRACKED. 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 23316043 ↗
• MalfunctionJun 18, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS NOT ALARMING NO FLOW OUT AS EXPECTED. THEY STATED THAT 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. NO ADDITIONAL INFORMATION WAS PROVIDED. COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286545 ↗
• MalfunctionJun 4, 2025Protective 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. MMD DID FOLLOW UP WITH THE INITIAL REPORTER, WHO STATED THAT THE COMPLAINT HAD OCCURRED DURING TESTING AND HAD NO EFFECT ON A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. [(B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145724 ↗
• MalfunctionJan 15, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP DID NOT ALARM NO FLOW OUT AS EXPECTED. THEY STATED THAT THE PUMP 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. NO OTHER INFORMATION WAS PROVIDED. [COMPLAINT: (B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160916 ↗
• MalfunctionJan 15, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP DID NOT ALARM NO FLOW OUT AS EXPECTED. THEY STATED THAT THE PUMP 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. NO OTHER INFORMATION WAS PROVIDED. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160743 ↗
• MalfunctionJan 9, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP FRONT HOUSING WAS BROKEN NEAR THE SENSORS. WHEN THE PUMP WAS RETURNED TO MMD FOR EVALUATION, THE NO FLOW IN 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 21119718 ↗
• MalfunctionJan 8, 2025Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP DID NOT ALARM NO FLOW OUT AS EXPECTED. THEY STATED THAT 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. [COMPLAINT: (B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107244 ↗
• MalfunctionDec 18, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE INITIAL REPORTER STATED THAT THE PUMP UNDER INFUSED AT A RATE THE MMD WOULD CONSIDER REPORTABLE. MMD DID FOLLOW UP WITH THE INITIAL REPORTER, WHO STATED THAT THE COMPLAINT OCCURRED DURING TESTING AND HAD NOT HAD ANY EFFECT ON A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. [COMPLAINT-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20970839 ↗
• MalfunctionOct 30, 2024Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP HAD A DAMAGED FRONT HOUSING. 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 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 20571559 ↗
• MalfunctionOct 30, 2024Protective Measures Problem; Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP HAD A DAMAGED FRONT HOUSING. 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 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 20571541 ↗
• MalfunctionSep 25, 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. MMD DID FOLLOW UP WITH THE INITIAL REPORTER WHO STATED THAT THEY DID NOT HAVE ANY ADDITIONAL INFORMATION ABOUT THE COMPLAINT BECAUSE IT WAS NOT AVAILABLE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT THAT WERE REPORTED. COMPLAINT:(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304735 ↗