MicroEZ Introducer 0828945Recalls & reported problems
Bard Access Systems, Inc. · Univ MI, 4.5 Fr, 7cm, · 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 00801741074653), received between May 6, 2016 and May 6, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Bent” (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
- Bent1
- Failure to Advance1
- Knotted1
- Physical Resistance1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2016Bent; Knotted; Failure to Advance; Physical Resistance
ON (B)(6) 2016 ¿ PER (B)(6), A FACILITY CONTACT REPORTED THAT ONE OF THEIR PICC NURSES WAS ATTEMPTING TO PLACE A POWERPICC 3CG. THE NURSE PLACED THE 21 GA INTRODUCER NEEDLE AND THE 0.018" WIRE BUT WHEN SHE TRIED TO ADVANCE THE WIRE, IT MET RESISTANCE. THE NURSE REMOVED THE WIRE AND REPORTED THAT IT WAS BENT. SHE OBTAINED ANOTHER WIRE, PASSED IT AND AGAIN HIT RESISTANCE. SHE THEN ATTEMPTED TO REMOVE THE WIRE BUT WAS UNABLE TO BECAUSE IT BECAME STUCK. THE REPORTING CONTACT, WHO SPOKE WITH (B)(6) AND IS ALSO A NURSE, VISITED THE FACILITY WHERE THIS OCCURRED AND DETERMINED THAT THE WIRE WAS STUCK IN THE TISSUE OF THE ARM AT THE NEEDLE INSERTION SITE. THE CONTACT THEN MADE A SMALL CUT AND THE WIRE CAME OUT. IT WAS NOTED THAT THE WIRE WAS IN A LOOSE KNOT ON THE END. A MIDLINE WAS PLACED INTO THE PATIENT¿S OTHER ARM.
Patient problems: No Information
MAUDE report 5638142 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page