VSI IPN029484Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156102876), received between Aug 12, 2020 and Mar 23, 2026 — classified as 2 injuries.
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. 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
- Material Separation1
- Separation Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2026Material Separation
IT WAS REPORTED THAT: "4F MIK SHEATH SEPARATED FROM HUB UPON REMOVAL. A CUTDOWN WAS PERFORMED TO REMOVE REMAINDER OF DEVICE."
Patient problems: Foreign Body In Patient
MAUDE report 24660110 ↗InjuryAug 12, 2020Separation Problem; Separation Problem
AS REPORTED: THE ACCESS SITE WAS CALCIFIED. THE 4F STIFFEN MICRO-INTRODUCER FAILED DURING ACCESS. SPECIFICALLY, THE DISTAL 5CM OF THE INTRODUCER BROKE OFF IN THE PATIENTS RIGHT FEMORAL ARTERY UPON PULLBACK BY PHYSICIAN. THERE WAS NO SIGNIFICANT RESISTANCE FELT DURING THE WITHDRAWAL, HOWEVER, THERE WAS A VERY SLIGHT BIT OF RESISTANCE RIGHT PRIOR TO THE INTRODUCER COMING OUT OF THE BODY. SITE REPORTED THAT THIS PRODUCT STILL HAS NOT BEEN RELEASED BY RISK MANAGEMENT AT SITE, SO IT WILL NOT BE ABLE TO BE SENT IMMEDIATELY. MULTIPLE ATTEMPTS WERE MADE TO THE SITE FOR RETURN OF THE DEVICE FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10395075 ↗
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- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
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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