MicroEZ Introducer 0828935Recalls & reported problems
Bard Access Systems, Inc. · Univ MI, 3.5 Fr, 7cm, · Class 2
Data updated Oct 13, 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 00801741038433), received between Sep 6, 2024 and Sep 6, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Frayed” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Frayed1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2024Material Frayed; Material Frayed
IT WAS REPORTED BY CUSTOMER THAT ACCESSED BRACHIAL VESSEL WITHOUT DIFFICULTY (ATTEMPTED TO VERIFY NEEDLE IN VESSEL WITH US AND DID SEE BLOOD RETURN) - GUIDEWIRE WOULD ONLY ADVANCE ABOUT CM (AXILLA REGION). ATTEMPTED TO INSERT 3 FR GAULT INTRODUCER (SMALLER INTRODUCER) WHICH WOULD NOT DILATE INTO VESSEL. PULLED DILATOR OUT OF INTRODUCER AND ATTEMPTED TO JUST INSERT DILATOR (GRADUALLY INCREASE OPENING) BUT HAD NO LUCK. THEN TRIED THE 3.5 MST INTRODUCER (COMES IN KIT WITH GUIDEWIRE THAT FRACTURED). AGAIN, WAS UNABLE TO GET INTRODUCER/DILATOR TO GO INTO THE VEIN. ATTEMPTED TO REMOVE INTRODUCER AND MET RESISTANCE, SO PULLED GUIDEWIRE AND INTRODUCER BACK OUT AT THE SAME TIME. ON REMOVAL SAW THE GUIDEWIRE UNRAVEL AND BROKEN PIECE OF WIRE NEAR TIP OF THE INTRODUCER. WHEN ATTEMPTING TO PULL GUIDEWIRE BACK IT WOULD COME OUT ABOUT 1 -2 CM THEN SUCK BACK IN. GPS (GENERAL PEDIATRIC SURGERY) WAS CALLED AND FELLOW CAME TO BEDSIDE AND WAS EVENTUALLY ABLE TO PULL OUT WIRE. XRAY OBTAINED AND NO INTERNAL GUIDEWIRE NOTED ON XRAY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 20164092 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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