VSI IPN039073Recalls & reported problems
Teleflex Incorporated · VSI Micro-Introducer Kit · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156103262), received between Mar 4, 2026 and Mar 4, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
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
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Material Separation
IT WAS REPORTED THAT: "THE PHYSICIAN OBTAINED ACCESS TO THE RCFA WHEN HE ATTACHED THE SYRINGE TO THE MICRO SHEATH AND PULLED NEGATIVE, HE NOTICED BUBBLES. WHEN HE ATTEMPTED TO WITHDRAW THE SHEATH, IT WAS SEPARATED FROM THE HUB. HE REMOVED THE SHEATH WITHOUT INCIDENT. ANOTHER DEVICE WAS USED SUCCESSFULLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24504635 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.