InfuseIT ZIT-520Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00607411916915), received between Jun 10, 2022 and Aug 27, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE HOSPITAL REPORTED THAT THE JOINT BETWEEN THE AIRBAG AND THE SLEEVE DETACHED DURING USE UNDER APPROPRIATE PRESSURE WITH A 500 ML INFUSION BAG. WHILE NO PATIENT HARM OR INJURY WAS REPORTED, RECURRENCE OF THIS ISSUE COULD DELAY INFUSION THERAPY AND LEAD TO SERIOUS PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910011 ↗
• MalfunctionAug 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, THE ADHESIVE ON THE LEFT BAG AND SLEEVE PEELED OFF DURING USE WHICH MADE IT IMPOSSIBLE TO APPLY PRESSURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850755 ↗
• MalfunctionAug 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, THE ADHESIVE ON THE LEFT BAG AND SLEEVE PEELED OFF DURING USE WHICH MADE IT IMPOSSIBLE TO APPLY PRESSURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22845208 ↗
• MalfunctionJul 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ALTHOUGH THE PRESSURE BAG HAD BEEN USED ONLY THREE TIMES, THE HOSPITAL REPORTED THAT THE ADHESIVE PART OF THE SLEEVE HAD COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588561 ↗
• MalfunctionJul 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCE A SINGLE INCIDENT THAT WAS REPORTATED: AFTER THE AIRBAG WAS PRESSURIZED TO 300 MMHG, THE END OF THE SLEEVE DETACHED FROM THE MAIN BODY OF THE AIRBAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401215 ↗
• MalfunctionMar 7, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE CONNECTION TUBE AND PRESSURE GAUGE DETACHED DURING PATIENT USE. WHILE NO PATIENT HARM OR INJURY WAS REPORTED, RECURRENCE OF THIS ISSUE COULD POTENTIALLY DELAY INFUSION THERAPY AND LEAD TO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21554227 ↗
• MalfunctionJan 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED BY THE CUSTOMER THAT: WE ARE EXPERIENCE PROBLEM WITH 500 ML BAGS THIS IS FROM DIFFERENT ORDERS BUT SAME PROBLEM SPLITTING ON THE SIDE OF GLUE/WELDING IS VERY DANGERS BECAUSE IS HAPPENING DURING PROCEDURE. THIS OCCURRED WITH THE SAME PRODUCT CODE ON 5 DIFFERENT DEVICES FROM THE SAME LOT. THEREFORE, 5 SEPARATE MDR REPORTS WILL BE SUBMITTED REGARDING THESE INCIDENTS. THIS IS THE FIRST OF THE FIVE: MDR NUMBERS WILL INCLUDE 3000219639-2025-00008, 3000219639-2025-00009, 3000219639-2025- 00007, 3000219639-2025-00010.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21225477 ↗
• MalfunctionJan 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED BY THE CUSTOMER THAT: WE ARE EXPERIENCE PROBLEM WITH 500 ML BAGS THIS IS FROM DIFFERENT ORDERS BUT SAME PROBLEM SPLITTING ON THE SIDE OF GLUE/WELDING IS VERY DANGERS BECAUSE IS HAPPENING DURING PROCEDURE. THIS OCCURRED WITH THE SAME PRODUCT CODE ON 5 DIFFERENT DEVICES FROM THE SAME LOT. THEREFORE, 5 SEPARATE MDR REPORTS WILL BE SUBMITTED REGARDING THESE INCIDENTS. THIS IS THE FIRST OF THE FIVE: MDR NUMBERS WILL INCLUDE 3000219639-2025-00007, 3000219639-2025-00008, 3000219639-2025- 00010, 3000219639-2025-00011.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21225445 ↗
• MalfunctionJan 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED BY THE CUSTOMER THAT: WE ARE EXPERIENCING A PROBLEM WITH 500 ML BAGS. THIS IS FROM DIFFERENT ORDERS BUT THE SAME PROBLEM - SPLITTING ON THE SIDE OF GLUE/WELDING. IT IS VERY DANGEROUS BECAUSE IT'S HAPPENING DURING PROCEDURES. THIS OCCURRED WITH THE SAME PRODUCT CODE ON 5 DIFFERENT DEVICES FROM THE SAME LOT. THEREFORE, 5 SEPARATE MDR REPORTS WILL BE SUBMITTED REGARDING THESE INCIDENTS. THIS IS THE FIRST OF THE FIVE: MDR NUMBERS WILL INCLUDE 3000219639-2025-00008, 3000219639-2025-00009, 3000219639-2025-00010, 3000219639-2025-00011.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21225443 ↗
• MalfunctionJan 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED BY THE CUSTOMER THAT: WE ARE EXPERIENCE PROBLEM WITH 500 ML BAGS THIS IS FROM DIFFERENT ORDERS BUT SAME PROBLEM SPLITTING ON THE SIDE OF GLUE/WELDING IS VERY DANGERS BECAUSE IS HAPPENING DURING PROCEDURE. THIS OCCURRED WITH THE SAME PRODUCT CODE ON 5 DIFFERENT DEVICES FROM THE SAME LOT. THEREFORE, 5 SEPERATE MDR REPORTS WILL BE SUBMITTED REGARDING THESE INCIDENTS. THIS IS THE FIRST OF THE FIVE: MDR NUMBERS WILL INCLUDE 3000219639-2025-00008, 3000219639-2025-00009, 3000219639-2025- 00007, 3000219639-2025-00011.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21225442 ↗
• MalfunctionJan 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED BY THE CUSTOMER THAT: WE ARE EXPERIENCE PROBLEM WITH 500 ML BAGS THIS IS FROM DIFFERENT ORDERS BUT SAME PROBLEM SPLITTING ON THE SIDE OF GLUE/WELDING IS VERY DANGERS BECAUSE IS HAPPENING DURING PROCEDURE. THIS OCCURRED WITH THE SAME PRODUCT CODE ON 5 DIFFERENT DEVICES FROM THE SAME LOT. THEREFORE, 5 SEPERATE MDR REPORTS WILL BE SUBMITTED REGARDING THESE INCIDENTS. THIS IS THE FIRST OF THE FIVE: MDR NUMBERS WILL INCLUDE 3000219639-2025-00007, 3000219639-2025-00009, 3000219639-2025- 00010, 3000219639-2025-00011.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21225440 ↗
• MalfunctionDec 10, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONNECTION TUBE AND PRESSURE GAUGE CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897749 ↗
• MalfunctionNov 26, 2024Mechanical Problem; Tear, Rip or Hole in Device Packaging; Mechanical Problem; Tear, Rip or Hole in Device Packaging

  THE ADHESIVE AREA BETWEEN THE SLEEVE AND THE AIRBAG HAS COME UNDONE. THE SLEEVE PART HAS PEELED OFF. WE CHECKED THE DEVICE AT OUR END AND CONFIRMED THE ISSUE. WE HAVE RECEIVED TWO NEW COMPLAINTS FROM THE SAME FACILITY AS THE PREVIOUSLY REPORTED 24-I-163I. THE LOT IS ALSO THE SAME: 230200827. WE HAVE CONFIRMED THAT THE ADHESIVE AREA BETWEEN THE SLEEVE AND THE AIRBAG HAS COME UNDONE. WE CONSIDER THERE MAY BE AN ADHESIVE FAILURE BETWEEN THE SLEEVE AND THE AIRBAG. EVEN AFTER 2 HOURS OF PRESSURIZATION, THE PRESSURE GAUGE MAINTAINED A READING OF 300 MMHG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788346 ↗
• MalfunctionOct 24, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE SLEEVE CAME OFF WHEN PRESSURIZED IT BY INJECTING SALINE SOLUTION BETWEEN THE AIRBAG AND THE SLEEVE. WE ARE USING IT ACCORDING TO THE INSTRUCTIONS, BUT SINCE THE SLEEVE CONTINUES TO BE DAMAGED, I WOULD LIKE TO KNOW THE CORRECT USAGE METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527384 ↗
• MalfunctionOct 10, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE SLEEVE TORE WHEN THEY TRIED TO PRESSURIZE IT BY INJECTING SALINE SOLUTION BETWEEN THE SLEEVE AND THE AIRBAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20420992 ↗
• MalfunctionSep 7, 2023Leak/Splash; Leak/Splash

  INFUSOR LEAKED AIR WITHIN 10 MINUTES OF BEGINNING USE.

  Patient problems: Insufficient Information

  MAUDE report 17703794 ↗
• MalfunctionJun 17, 2022Decrease in Pressure

  THE PRESSURE DROPPED AFTER 1 HOUR OF USE.

  Patient problems: Insufficient Information

  MAUDE report 14737034 ↗
• MalfunctionJun 16, 2022Disconnection

  THE GAUGE DISCONNECTED FROM THE TUBING.

  Patient problems: Insufficient Information

  MAUDE report 14717432 ↗
• MalfunctionJun 10, 2022Disconnection

  THE GAUGE DISCONNECTED FROM THE TUBING.

  Patient problems: Insufficient Information

  MAUDE report 14658263 ↗