VSI IPN916034Recalls & reported problems
Teleflex Incorporated · 7265V · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156107123), received between Oct 27, 2021 and Oct 27, 2021 — classified as 1 injury.
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
- No Apparent Adverse Event1
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.
InjuryOct 27, 2021No Apparent Adverse Event; No Apparent Adverse Event
AS REPORTED: BRACHIAL ARTERY ACCESS, PHYSICIAN STUCK WITH THE NEEDLE AND DELIVERED THE MICRO WIRE AND HAD RESISTANCE. WHILE REMOVING THE WIRE, THE WOUND TIP UNRAVELED. PULLED THE NEEDLE OUT OF THE BODY AND STILL HAD TO REMOVE MORE WOUND TIP OF WIRE BUT IT ALL CAME OUT. THE NEEDLE SEEMED TO HAVE BEEN INSERTED MORE INTO THE VESSEL AFTER THE WIRE MET RESISTANCE AS THE WIRE HAS AN ACUTE BEND AT THE DISTAL TIP LIKE THE NEEDLE PINCHED/KINKED IT DISALLOWING IT TO BE WITHDRAWN SMOOTHLY. THE PATIENT IS FINE, NO COMPLICATIONS FROM THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12703923 ↗
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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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