MicroEZ Introducer 0678945Recalls & reported problems
Bard Access Systems, Inc. · 4.5 Fr. Universal, · Class 2
All models of MicroEZ Introducer (12)
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 00801741038372), received between Mar 7, 2018 and Sep 29, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Difficult to Remove1
- Material Frayed1
- Migration or Expulsion of Device1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2021Material Frayed; Material Frayed
IT WAS REPORTED "THE WIRE FROM THE INTRODUCER KIT THEY OPENED UNRAVELED AFTER PULLING IT OUT OF THE PATIENT DURING AN UNSUCCESSFUL PICC INSERTION." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12550390 ↗InjuryMar 7, 2018Break; Migration or Expulsion of Device; Difficult to Remove
IT WAS REPORTED BY THE FACILITY THAT THE LINE WAS PLACED SOME TIME IN (B)(6) 2017 AND A PIECE OF THE GUIDEWIRE BROKE OFF DURING THE PROCEDURE. IT WAS STATED THE MIGRATED SECTION HAS NOT BEEN REMOVED FROM THE PATIENT. NO OTHER INFORMATION AS BEEN PROVIDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7322488 ↗
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- 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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