VSI IPN039059Recalls & reported problems
Teleflex Incorporated · VSI Micro-Introducer Kit · Class 2
Data updated Oct 13, 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 10841156103125), received between Aug 25, 2020 and Aug 25, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Separation Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Separation Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2020Separation Problem; Separation Problem
AFTER GAINING ACCESS TO THE LEFT COMMON FEMORAL ARTERY WITH A 5F MICRO INTRODUCER, A GUIDEWIRE WAS INSERTED BUT WAS UNABLE TO ADVANCE PAST AN ILIAC STENOSIS. WHEN THE GUIDEWIRE WAS REMOVED, THE HUB OF THE SHEATH CAME OFF AND THE SHAFT REMAINED INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY SNARE THE SHAFT FROM THE CONTRA-LATERAL SIDE AND REMOVE IT FROM THE PATIENT IN ITS ENTIRETY. THE PATIENT IS DOING FINE WITH NO ISSUES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10451547 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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