MicroEZ Introducer 0928945Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741074691), received between Feb 26, 2025 and May 5, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Material Frayed2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2026Material Deformation
IT WAS REPORTED INTRODUCER HAD A BURR OF PLASTIC ON THE END AND WASN'T USEABLE. THE PATIENT EXPERIENCED MULTIPLE TRAUMATIC ATTEMPTS WHEN TRYING TO PUSH THE INTRODUCER DILATOR THROUGH SKIN AND WHEN IT WOULDN'T IT WAS REMOVED OVER WIRE AND INSPECTED FURTHER AND THAT'S WHEN THE PLASTIC BURR WAS SEEN ON IT PEEL AWAY PART OF THE DILATOR. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086655 ↗MalfunctionMar 5, 2025Material Frayed; Material Frayed
IT WAS REPORTED PER MEDWATCH THAT WHILE ATTEMPTING TO REMOVE THE GUIDEWIRE, THE WIRE BECAME STUCK. AFTER ANOTHER ATTEMPT, THE WIRE SPIRALED APART AND LENGTHENED SIGNIFICANTLY BUT WAS STILL STUCK IN PATIENT'S ARM. USING FORCE WITH THE WIRE, IT STILL UNCOILED AND WAS EVENTUALLY REMOVED WITH THE INTRODUCER. STANDARD WIRE LENGTH IS 50CM, THE UNCOILED WIRE LENGTH MEASURED 85CM. MEDICATIONS AND TESTS WERE DELAYED. NO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21527946 ↗MalfunctionFeb 26, 2025Material Frayed; Material Frayed
IT WAS REPORTED WE HAD A GUIDE WIRE UNRAVEL IN A PATIENT. THE METAL TIP ZIG ZAG WIRE BECAME STUCK IN THE PATIENT NEEDED TO BE REMOVED WITH FORCE. PATIENT UPSET, REQUIRED XRAY TO CONFIRM NO WIRE RETAINED. PICC INSERTION ABORTED AND PATIENT REFUSED ANOTHER ATTEMPT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21471469 ↗
Other INTRODUCER, CATHETER devices
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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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