VSI Micro-Introducer Kit 7266VRecalls & reported problems
Vascular Solutions, Inc. · VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inch or 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick. · Class 2
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 M2067266V0), received between Apr 18, 2018 and Apr 4, 2019 — classified as 1 injury, 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Hole In Material1
Patient problems
- No Consequences Or Impact To Patient1
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT WAS HAVING A CARDIAC CATHETERIZATION THROUGH THE RIGHT FEMORAL VEIN. THE VEIN WAS ACCESSED USING A MICRO PUNCTURE NEEDLE. THE NEEDLE WAS TAKEN OUT AND MICRO PUNCTURE SHEATH BROKE OFF FROM THE BASE WITH SHEATH STILL INSIDE THE SOFT TISSUE AND VEIN WITH THE WIRE STILL PRESENT. THE CARDIOLOGIST WAS UNABLE TO RETRIEVE THE SHEATH SUPERFICIALLY. A GENERAL SURGEON WAS CALLED IN TO PERFORM A RIGHT GROIN EXPLORATION TO REMOVE THE SHEATH.
Patient problems: Vessel Or Plaque, Device Embedded In
MAUDE report 8484200 ↗MalfunctionApr 18, 2018Hole In Material; Hole In Material
DR. WAS USING MIK FOR ACCESS IN A VARILASE CASE. WHEN HE TRIED TO ADVANCE THE 035"" J-TIP WIRE THROUGH THE MIK SHEATH, HE FELT RESISTANCE. DR. THAN REMOVED THE J-TIP WIRE, AND USED THE MIK MANDREL TO ADVANCE AND REMOVED THE MIK SHEATH. THE TIP OF THE SHEATH SHOWED A PUNCTURE AT THE DISTAL TIP. MIK SHEATH REMOVED AND PLACED IN BIOHAZARD BAG WITH PACKAGING. NO PATIENT IMPACT OR INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7441273 ↗
Other Introducer, Catheter devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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