MicroEZ Introducer 0228945Recalls & reported problems
Bard Access Systems, Inc. · 4.5F MicroEZ Microintroducer Kit · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741038235), received between May 8, 2024 and May 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Difficult or Delayed Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2024Detachment of Device or Device Component; Difficult or Delayed Separation; Detachment of Device or Device Component; Difficult or Delayed Separation
IT WAS REPORTED, "I WAS PLACING A PICC LINE IN THE ABOVE PATIENT. I WAS PREPARING TO PUT THE PICC LINE THROUGH THE INTRODUCER SHEATH AND TWISTED AND PULLED TO REMOVE THE DILATOR FROM THE INTRODUCER SHEATH. THE PART OF THE DILATOR THAT YOU HOLD ON TO BROKE FREE FROM THE DILATOR AND LEFT THE REMAINDER OF THE DILATOR INSIDE THE INTRODUCER SHEATH. I WAS ABLE TO SAFELY REMOVE THE DILATOR FROM THE SHEATH BY GRABBING ON TO THE PORTION OF DILATOR STILL PROTRUDING FROM THE END OF THE SHEATH (FORTUNATELY A FEW MILLIMETERS OF DILATOR WAS EXPOSED). FROM THIS POINT I WAS ABLE TO RESUME PLACING THE PICC WITHOUT ANY FURTHER INCIDENT. THERE WAS NO PATIENT INJURY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19274733 ↗
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- 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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