VSI Micro-Introducer Kit 7242VRecalls & 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
- 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 M2067242V0), received between Jun 19, 2018 and Jun 19, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of 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 Component1
- Difficult to Remove1
- Entrapment of Device1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2018Detachment Of Device Component; Entrapment of Device; Difficult to Remove; Detachment Of Device Component; Entrapment of Device; Difficult to Remove
PER MEDWATCH RECEIVED UF/IMPORTER REPORT (B)(4). INTERVENTIONAL CARDIOLOGIST AT INITIATION OF LEFT HEART CATH USED 4F MICRO-PUNCTURE KIT CANNULATED LEFT FEMORAL VEIN WHILE ATTEMPTING LEFT FEMORAL ACCESS. WHILE IC ATTEMPTED TO REMOVE SHEATH FROM THE VEIN, APPROXIMATELY 2 CM OF SHEATH SHEARED OFF AND REMAINED IN PATIENT'S LEFT FEMORAL SITE. RETAINED SHEATH COULD NOT BE VISUALIZED WITH FLUOROSCOPY. VASCULAR SURGEONS CONSULTED AND DETERMINED NO VASCULAR INTERVENTION NEEDED AT THIS TIME. PATIENT WITH NO COMPLAINTS OF PAIN OR DISCOMFORT. IT IS BELIEVED RETAINED SHEATH PORTION MAYBE IN SCAR TISSUE AT LEFT FEMORAL SITE. ADDITIONAL INFORMATION RECEIVED: PATIENT WAS DISCHARGED HOME - (B)(6) 2018. PT REPORTED NO DISCOMFORT AT THE LEFT FEMORAL SITE AT THE TIME OF DISCHARGE. DOCUMENTATION REFLECTS NO KNOWN HARM TO PATIENT ASSOCIATED WITH RETENTION OF SHEARED MICROPUNCTURE SHEATH AT THE TIME OF DISCHARGE. THE PRACTITIONER REPORTED THAT THE SHEATH SHEARED OFF AS HE WAS REMOVING SHEATH FROM LEFT FEMORAL SITE. DOCUMENTATION REFLECTS THAT THE PRACTITIONER CONSULTED W VASCULAR SURGEONS AND OTHER INTERVENTIONAL CARDIOLOGISTS AND NO SPECIFIC THERAPY WAS INDICATED AT THE TIME REGARDING THE LOSS OF THE S
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7614227 ↗
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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