VSI Micro-Introducer Kit 7195VRecalls & 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 18, 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 M2067195V0), received between Nov 7, 2018 and Nov 29, 2018 — 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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Leak/Splash1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
COPY OF MDR AND LETTER RECEIVED OCTOBER 30, 2018 FROM HOSPITAL SITE. PATIENT WAS TO HAVE HEART CATH. ACCESS TO RIGHT FEMORAL ARTERY. 4F MICRO-PUNCTURE INTRODUCER INSERTED ON WIRE, SCALPEL WAS USED TO WIDEN INSERTION SITE, PROXIMAL HALF MICROPUNCTURE SHEATH REMOVED FROM WIRE NOTING DISTAL PORTION OF SHEATH REMAINED IN THE FEMORAL ARTERY. WE WERE UNABLE TO RETRIEVE DISTAL PORTION OF SHEATH. VASCULAR SURGERY CONSULTED AND TOOK PATIENT TO THE OR TO RETRIEVE SHEATH. PATIENT REMAINED STABLE THROUGHOUT THE INCIDENT AND PATIENT ADMITTED TO HOSPITAL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8115188 ↗MalfunctionNov 7, 2018Leak/Splash; Leak/Splash
MICROPUNCTURE SHEATH WAS INSERTED INTO RIGHT ARM FISTULA. CONTRAST WAS INJECTED INTO MICROPUNCTURE SHEATH. CONTRAST SQUIRTED OUT OF HOLE IN SHEATH, WHERE THE TUBE MEETS THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8046873 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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