Medline Industries, Inc. VASC1307Recalls & reported problems
Medline Industries, Inc. · LHK- HMWB/HMTW HOSPITAL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327057855), received between Mar 3, 2025 and Sep 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Disconnection” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Mar 24, 2026Class IOpen, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2144-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Disconnection1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Disconnection
It was reported that "The control syringe also started to back off the manifold during the setup and would unravel itself.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946465 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
It was reported that Waste bag leaking.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930978 ↗MalfunctionMar 3, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT WHEN USING THE SYRINGES WITH A MANIFOLD, THE SYRINGE "GETS STUCK OR VERY HARD TO MOVE THE PLUNGER AFTER FEW INJECTIONS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21510077 ↗
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- Medline Industries, Inc. ECVC6505Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
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 · each recall links to the FDA recall notice
- 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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