MicroEZ Introducer 0688950Recalls & reported problems
Bard Access Systems, Inc. · Universal, 5 Fr, Safety · Class 2
All models of MicroEZ Introducer (12)
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 00801741038426), received between Jan 29, 2016 and Jan 29, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Knotted” (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
- Knotted1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2016Knotted
IT WAS REPORTED THAT IN PREPARATION FOR PICC INSERTION, THE PROVIDER ACCESSED THE PATIENT'S RIGHT BASILICA VEIN. A MICROEZ INTRODUCER GUIDE WIRE (35CM) WAS THREADED WITH RESISTANCE. THE INTRODUCER WAS THREADED OVER WIRE. WHEN PROVIDER WAS TRYING TO REVERSE THE WIRE THEY WERE UNABLE TO DO SO. AN X-RAY WAS DONE AND THE ALLEGED KNOT IN THE GUIDE WIRE WAS NOTED. AN INCISION WAS MADE TO REMOVE IT AND THE PATIENT REQUIRED SUTURES TO CLOSE THE WOUND.
Patient problems: No Code Available
MAUDE report 5398685 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
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- 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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