Medline Industries, Inc. DYNJ51449CRecalls & reported problems
Medline Industries, Inc. · RAPID ECMO RESPONSE KIT-LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10193489470840), received between Mar 3, 2023 and Mar 26, 2024 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device3
- Break1
- Connection Problem1
Patient problems
- Air Embolism3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT AN ENTERAL FEEDING SYRINGE COMPONENT DID NOT ATTACH TO A FEEDING TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18980715 ↗InjurySep 6, 2023Air/Gas in Device; Air/Gas in Device
InjurySep 6, 2023Air/Gas in Device; Air/Gas in Device
InjurySep 6, 2023Air/Gas in Device; Air/Gas in Device
InjuryMar 3, 2023Break; Break
PIECE FELL OFF INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16479721 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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