VSI IPN029495Recalls & reported problems
Teleflex Incorporated · VSI Micro-Introducer Kit · Class 2
All models of VSI (31)
Data updated Oct 18, 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 10841156102982), received between Jan 23, 2020 and Jan 23, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: PART OF THE SHEATH SHEARED OFF INTO PATIENT AND REQUIRES SURGERY. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH FROM SITE RECEIVED 02JAN20: LEFT HEART CATHETER PROCEDURE WAS ABORTED AFTER SHEATH WAS DISLODGED FROM BODY AFTER PLACEMENT. THE SHEATH REQUIRED SURGICAL REMOVAL AND A RIGHT COMMON FEMORAL ARTERY REPAIR BY VASCULAR SURGERY. PATIENT WAS TRANSFERRED TO ICU FOR STABILIZATION AND MONITORING. RELEVANT TESTS/LABORATORY DATES: NC MYOCARDIAL PERFUSION (B)(6) 2019 OTHER RELEVANT HISTORY INCLUDES: ELEVATED TROPONIN, HYPERTENSION, CHEST PAIN, ESRD ON HEMODIALYSIS, CORONARY ARTERY DISEASE, A -FIBRILLATION, SINUS NODE DYSFUNCTION.
Patient problems: Vessel Or Plaque, Device Embedded In
MAUDE report 9621926 ↗
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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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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