Medline Industries, Inc. VASC1489ARecalls & reported problems
Medline Industries, Inc. · LHK, US, NORTHBAY MED CENTER · Class 2
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 10198459155024), received between Sep 25, 2026 and Sep 28, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Feb 25, 2026Open, 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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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 · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918109 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
It was reported that "The manifold end snapped off" and "we just had another one break this weekend at the same location."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899317 ↗
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- Halyard SAMM066-15_0017Avid Medical, Inc. · Cardiac catheterization kit3 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.