Medline DYNJAAPI1000SRecalls & reported problems
Medline Industries, Inc. · 1000ML,PRESSURE INFUSER W/STOPCOCK · Class 1
- Adverse event reports
- 9
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10080196759620), received between May 16, 2023 and Sep 30, 2026 — classified as 1 death, 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (3 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.
Reports received per month
Most reported problems
Device problems
- Deflation Problem3
- Decrease in Pressure2
- Gas/Air Leak2
- Material Split, Cut or Torn2
- Unintended Deflation2
- Insufficient Device Problem Information1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Air Embolism1
- Insufficient Information1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Deflation Problem
Patient problems: Insufficient Information
MAUDE report 50952424 ↗MalfunctionSep 30, 2026Unintended Deflation
It was reported that the pressure bag is not staying inflated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945610 ↗MalfunctionSep 24, 2026Gas/Air Leak; Material Split, Cut or Torn
It was reported that "2ea of the bags are leaking."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882640 ↗MalfunctionSep 22, 2026Deflation Problem; Decrease in Pressure
It was reported that "Bags are not holding pressure".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854746 ↗MalfunctionSep 11, 2026Deflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737120 ↗MalfunctionSep 2, 2026Unintended Deflation
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 50573086 ↗MalfunctionAug 31, 2026Material Separation; Material Split, Cut or Torn
It was reported that "we are having a issue with the single use pressure bags ripping on the side, when we pump them up."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50519245 ↗DeathJan 13, 2026Decrease in Pressure; Gas/Air Leak
ACCORDING TO THE FACILITY, ON (B)(6) 2025, THE PRESSURE BAG SLOWLY DEFLATED. THE "PRESSURE WAS SET TO 300MMHG FOR ARTERIAL LINE. PATIENT'S BP VIA THE ARTERIAL LINE WAS NOTED TO BE LOWER THAN PREVIOUS READINGS, WAVEFORM DAMPENED, LINE WAS FLUSHED AND RECALIBRATED, PRESSURE BAG NOTED TO DEFLATE TO 200MMHG."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058535 ↗InjuryMay 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
Other INFUSOR, PRESSURE, FOR I.V. BAGS devices
- Medex MX4705Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS36 reports
- InfuseIT ZIT-520Salter Labs · INFUSOR, PRESSURE, FOR I.V. BAGS19 reports
- Medex MX4810Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS15 reports
- Medex MX4805Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS9 reports
- Medline DYNJPI500CMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS7 reports
- Medline DYNJAAPI500SMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS6 reports
- Vital Signs IN800048Hygia Health Services, Inc. · Infusor, Pressure, For I.V. Bags3 reports
- Vital Signs™ IN800012Airlife · INFUSOR, PRESSURE, FOR I.V. BAGS3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.