VSI IPN028423Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156102739), received between May 8, 2024 and May 8, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED THAT: THIS PATIENT WAS IN A MITRAL CLIP PROCEDURE. A PERICARDIAL EFFUSION WAS NOTED AFTER THE MITRAL CLIPS WERE RELEASED AND PERICARDIOCENTESIS WAS PERFORMED. DURING THE PERICARDIOCENTESIS, A MICRO INTRODUCER SHEATH WAS INSERTED, AND THE PHYSICIAN HAD A DIFFICULT TIME ADVANCING THE GUIDEWIRE. AFTER ATTEMPTING TO REWIRE THE MICRO SHEATH, THE MICRO INTRODUCER SHEATH BROKE, AND THE PHYSICIAN WAS UNABLE TO RETRIEVE THE SHEATH FROM THE PATIENT'S BODY. CVTS (CARDIOVASCULAR AND THORACIC SURGERY) WAS CONTACTED, AND THE OR (OPERATING ROOM) TEAM ARRIVED TO CATH LAB TO PERFORM A SMALL PERICARDIAL WINDOW TO RETRIEVE THE SHEATH. THE RETAINED PIECE OF SHEATH WAS RETRIEVED SUCCESSFULLY, AND FRAGMENTS WERE GIVEN TO CATH LAB MANAGER.
Patient problems: Foreign Body In Patient
MAUDE report 19268124 ↗
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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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