VSI IPN916015Recalls & reported problems
Teleflex Incorporated · 7208V · Class 2
All models of VSI (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156107260), received between Oct 27, 2021 and May 17, 2023 — classified as 1 injury, 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
- Material Separation1
- Physical Resistance/Sticking1
- Unraveled Material1
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
InjuryMay 17, 2023Material Separation; Unraveled Material; Physical Resistance/Sticking; Material Separation; Unraveled Material; Physical Resistance/Sticking
IT WAS REPORTED THAT: DURING ACCESS BY THE PHYSICIAN, HE WAS UNABLE TO ADVANCE THE WIRE INTO THE VESSEL TO A DEPTH HE WANTED. HE ATTEMPTED TO REMOVE THE WIRE WHILE THE NEEDLE WAS STILL IN PLACE AND ENCOUNTERED DIFFICULTY REMOVING THE WIRE. HE INCREASED THE AMOUNT OF FORCE TO REMOVE THE WIRE AND NOTICED THE WIRE WAS ""UNRAVELED"". FLUOROSCOPY REVEALED A SMALL PIECE OF THE WIRE TIP IN THE WALL OF THE VESSEL. ANGIOGRAM REVEALED NORMAL FLOW IN THE VESSEL. THE PROCEDURE WAS COMPLETED USING A MIK WITH A STIFFEN DILATOR. PATIENT WAS REPORTED AS FINE POST PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT. A FOLLOW UP REPORT WILL BE SUBMITTED ON RECEIPT OF THIS INFORMATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 16944354 ↗MalfunctionOct 27, 2021Fracture; Fracture
AS REPORTED: DURING THE PROCEDURE THE WIRE FROM THE MICRO-INTRODUCER KIT SHREDDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12708351 ↗
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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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