VSI Micro-Introducer Kit 9217VRecalls & 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 M2069217V0), received between Jul 20, 2017 and Jul 20, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Or Device Fragments Location Unknown” (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
- Device Or Device Fragments Location Unknown1
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.
InjuryJul 20, 2017Device Or Device Fragments Location Unknown; Device Or Device Fragments Location Unknown
FOUR (4) FRENCH SHEATH AND DILATOR WERE ADVANCED OVER THE WIRE. WHEN THE DILATOR AND THE WIRE PULLED OUT, THE HUB OF THE SHEATH WAS PULLED OUT WITHOUT THE BODY OF THE SHAFT OF THE SHEATH. THIS WAS CUT/GOT SEPARATED FOR AN UNKNOWN REASON. TO RETRIEVE THE SHAFT OF THE SHEATH, OBTAINED A CONTRALATERAL ACCESS IN THE LEFT GROIN. A MICROPUNCTURE NEEDLE WAS USED. WE UPGRADED IT FOR A 6 FRENCH SHEATH. ANGIOGRAPHY WAS OBTAINED WITH THE TIP OF THE CATHETER IN THE LEFT EXTERNAL ILIAC ARTERY. WE ADVANCED WIRE AND CATHETER. SELECTIVE ABDOMINAL AORTOGRAM WAS PERFORMED. WE CROSSED OVER TO THE CONTRALATERAL SIDE USING THE CATHETER AND THIS WIRE. WE THEN ADVANCED THE WIRE DOWN THE SFA. AFTER THAT WE EXCHANGED THIS SYSTEM OUT FOR A 7 FRENCH SHEATH, 45 CM. THE TIP OF THE CATHETER WAS IN THE RIGHT EXTERNAL ILIAC ARTERY. TRIED TO SNARE IT INITIALLY, BUT THIS DID NOT WORK. THEN TRIED TO ADVANCE WIRE INTO THE SHEATH THAT CUT TO EXTERNALIZE IT BUT THIS DID NOT WORK EITHER. TRIED USING A DIFFERENT WIRE BUT THIS DID NOT WORK EITHER. OBTAINED A SURGICAL CONSULT. AFTER THAT, OBTAINED A RIGHT COMMON FEMORAL ARTERIAL ACCESS USING THE MICROPUNCTURE NEEDLE, ADVANCED A 6 FRENCH SHEATH. THEN WAS ABLE TO SNARE THE 4
Patient problems: Vessel Or Plaque, Device Embedded In
MAUDE report 6728278 ↗
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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