Infinity Enteral Feeding Pump INFP01Recalls & reported problems

Summary

The FDA's MAUDE database contains 207 adverse event reports that list this exact device (DI 10814844000181), received between Jan 17, 2024 and Sep 28, 2026 — classified as 1 death, 206 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (175 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 25 most recent of 207 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918908 ↗
• MalfunctionSep 28, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918904 ↗
• MalfunctionSep 22, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858572 ↗
• MalfunctionSep 15, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778540 ↗
• MalfunctionSep 15, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778536 ↗
• MalfunctionAug 11, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212994 ↗
• MalfunctionJul 27, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50007994 ↗
• MalfunctionJul 27, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50007991 ↗
• MalfunctionJul 8, 2026Insufficient Flow or Under Infusion

  THE INITIAL REPORTER STATED THAT THE PUMP WAS ALARMING DOSE DONE "A MINUTE AFTER FEEDING STARTED". THEY STATED THAT THE PUMP WAS PROGRAMMED AT A RATE OF 500 ML AND A DOSE OF 200 ML. THEY STATED THAT THEY TRIED TO TURN THE PUMP OFF AND BACK ON, BUT THAT THEY WERE UNABLE TO TURN IT OFF. MMD DID FOLLOW UP WITH THE INITIAL REPORTER WHO STATED THAT THE PATIENT HAD NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THE COMPLAINT AND THAT THEY HAD NO ADDITIONAL INFORMATION TO PROVIDE. (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750238 ↗
• MalfunctionJun 23, 2026Protective 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 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 25597847 ↗
• MalfunctionJun 10, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP HAD BROKEN HINGES. 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 25461629 ↗
• MalfunctionMay 26, 2026Failure to Deliver

  THE INITIAL REPORTER STATED THAT SOMETIMES THE PUMP WAS NOT DELIVERING FORMULA AS EXPECTED. THEY STATED THAT IT WOULD RANDOMLY SOUND LIKE IT WAS RUNNING, BUT NOTHING WOULD BE DELIVERING. 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 25284982 ↗
• MalfunctionMay 6, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WOULD QUIT RUNNING AND NEED TO BE RESTARTED. THEY STATED THAT THE PUMP DID NOT ALARM. MMD DID FOLLOW UP WITH THE INITIAL REPORTER, AND THEY STATED THAT THE COMPLAINT DID NOT HAVE ANY ADVERSE EFFECTS ON THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094246 ↗
• MalfunctionApr 21, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP HAD A DAMAGED FRONT HOUSING AND A MISSING DOOR. 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 24942783 ↗
• MalfunctionApr 14, 2026Insufficient Flow or Under Infusion

  THE INITIAL REPORTER STATED THAT THE PUMP WAS UNDER INFUSING. THEY STATED THE PUMP WAS SETTINGS WERE 125ML/HR RATE AND 100 ML DOSE AND THAT 19 ML WAS DELIVERED. 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 24875056 ↗
• MalfunctionApr 14, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP HAD BROKEN HINGES AND DAMAGE TO THE FRONT HOUSING AND DOOR. WHEN THE PUMP WAS RETURNED TO MMD FOR EVALUATION, THE LOAD SET 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. COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875047 ↗
• MalfunctionApr 9, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WOULD QUIT RUNNING AND NEED TO BE RESTARTED. THEY STATED THAT THE PUMP DID NOT ALARM. MMD DID FOLLOW UP WITH THE INITIAL REPORTER, AND THEY STATED THAT THE COMPLAINT HAD OCCURRED DURING TESTING AND HAD NO EFFECT ON ANY PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832733 ↗
• MalfunctionApr 9, 2026Failure to Deliver

  THE INITIAL REPORTER STATED THAT THE PUMP APPEARED TO BE RUNNING BUT WAS NOT DELIVERING AS EXPECTED. THEY REPORT USING KATE FARMS FORMULA IN THE PUMP. MMD DID FOLLOW UP WITH THE INITIAL REPORTER AND THEY STATED THE PATIENT DID NOT HAVE ANY ADVERSE EFFECTS DUE TO THE COMPLAINT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832724 ↗
• MalfunctionMar 19, 2026Failure to Deliver

  THE INITIAL REPORTER STATED THAT THE PUMP APPEARED TO BE RUNNING BUT WAS NOT DELIVERING AS EXPECTED. THEY REPORT USING COMPLEAT PEDIATRIC FORMULA. MMD DID NOT FOLLOW UP WITH THE INITIAL REPORTER BECAUSE AT THE TIME OF THE COMPLAINT THEY STATED THE PATIENT DID NOT HAVE ANY ADVERSE EFFECTS DUE TO THE COMPLAINT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640644 ↗
• MalfunctionMar 19, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS ALARMING NO FLOW IN ALMOST IMMEDIATELY AFTER THEY PRESSED THE RUN BUTTON TO START THE FEEDING. THEY STATED THAT THIS RESULTED IN A FOUR HOUR DELAY OF THERAPY WHILE THEY WAITED FOR A REPLACEMENT PUMP TO BE DELIVERED. THEY STATED THEY DID HAVE THE ABILITY TO SUPPLEMENT THE FEEDING, BUT CHOSE NOT TO UTILIZE THE ALTERNATE FEEDING METHOD. MMD DID FOLLOW UP WITH THE INITIAL REPORTER WHO STATED THAT THERE WERE NO ADVERSE EFFECTS AS A RESULT OF THE COMPLAINT. THEY DID NOT PROVIDE ANY ADDITIONAL INFORMATION. [COMPLAINT-(B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640630 ↗
• MalfunctionFeb 17, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS ALARMING NO FLOW IN ALMOST IMMEDIATELY AFTER THEY PRESSED THE RUN BUTTON TO START THE FEEDING. THEY STATED THAT THIS RESULTED IN AN EIGHT HOUR DELAY OF THERAPY WHILE THE PATIENT WAS AT SCHOOL. MMD DID FOLLOW UP WITH THE INITIAL REPORTER WHO STATED THAT THERE WERE NO ADVERSE EFFECTS AS A RESULT OF THE COMPLAINT. THEY STATED THAT THE PATIENT WAS ABLE TO EAT BY MOUTH AFTER THEY WHEN HOME AND THAT A REPLACEMENT PUMP WAS DELIVERED. THEY DID NOT PROVIDE ANY ADDITIONAL INFORMATION. [COMPLAINT: (B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368563 ↗
• MalfunctionFeb 17, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP WAS NOT ALARMING NO FLOW OUT WHEN FOOD WAS NOT BEING DELIVERED. THEY ALSO STATED THAT THE PUMP RESETTING ITSELF. MMD DID FOLLOW UP WITH THE INITIAL REPORTER, AND THEY STATED THAT THERE HAD BEEN NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE COMPLAINT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368558 ↗
• MalfunctionFeb 10, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP FRONT HOUSING AND HINGES WERE DAMAGED. WHEN THE PUMP WAS RETURNED TO MMD FOR EVALUATION, LOAD SET AND NO FLOW OUT ALARMS DID NOT OPERATE 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 24307731 ↗
• MalfunctionFeb 3, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP DID NOT ALARM LOAD SET AS EXPECTED. THEY STATED THAT IT FAILED TO ALARM. 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 24250809 ↗
• MalfunctionJan 29, 2026Protective Measures Problem

  THE INITIAL REPORTER STATED THAT THE PUMP CRACKS IN THE FRONT HOUSING. WHEN THE PUMP WAS RETURNED TO MMD FOR EVALUATION, LOAD SET 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 24211804 ↗