VSI IPN028429Recalls & reported problems
Teleflex Incorporated · VSI Micro-Introducer Kit · Class 2
All models of VSI (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10841156102791), received between Dec 8, 2020 and Dec 8, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture1
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.
MalfunctionDec 8, 2020Fracture; Fracture
AS REPORTED: A 5FR MICRO- INTRODUCER WAS USED FOR A VASCULAR ACCESS RIGHT FEMORAL VEIN. THE WIRE WOULD NOT ADVANCE THROUGH THE NEEDLE. PHYSICIAN PULLED BOTH WIRE AND NEEDLE OUT. THE WIRE STRETCHED, AND THE TIP OF THE WIRE BROKE OFF. WE CHECKED UNDER FLUOROSCOPY AND THE TIP WAS IN THE RIGHT GROIN. PHYSICIAN STATED THE WIRE WAS EXTRAVASCULAR AND WOULD FOLLOW UP WITH THE PATIENT. THE EXAM WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10971782 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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