Medline Industries, Inc. VASC1416Recalls & reported problems
Medline Industries, Inc. · LHK - MT SINAI HOSPITAL(LUM) · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327409609), received between Feb 19, 2025 and May 20, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (2 reports).
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
- Feb 25, 2026Class IIOpen, Classified
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Z-1835-2026 · Root cause: No Marketing Application · Recall details · FDA record ↗
Most reported problems
Device problems
- Connection Problem2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THERE HAVE BEEN "MULTIPLE" INCIDENTS OF THE SYRINGE "COMING UNDONE FROM THE MANIFOLD WHEN THEY GO TO ATTACH IT UPON FIRST TRY".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055971 ↗MalfunctionFeb 19, 2025Connection Problem; Connection Problem
ISSUES WITH THE MANIFOLD AND SYRINGE CONNECTION.
Patient problems: Insufficient Information
MAUDE report 21411163 ↗
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- Medline Industries, Inc. ECVC5540ACenturion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC2745Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- 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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