MicroEZ Introducer 0678950Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741038389), received between Apr 1, 2016 and Nov 8, 2024 — classified as 7 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT CUSTOMER PULLED WIRE OUT AND IT PROCEEDED TO UNRAVEL. HAD TO GET A NEW WIRE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646088 ↗
• MalfunctionApr 25, 2024Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT WE THEN OBTAINED WIRE, THIS TIME FROM A 5F LOT # REHS1567. THIS WIRE WAS INSERTED INTO THE PATIENT WITHOUT DIFFICULTY, BUT, AFTER REMOVING IT, WE REALIZED THERE WAS A SMALL BALL OF WIRE ON THE END. IT WAS SMOOTH AND ROUND SO IT DID NOT CAUSE ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182144 ↗
• MalfunctionJun 2, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER ¿I WAS DOING A PICC LINE TODAY AND IN THE MICROEZ MICROINTRODUCER KIT, THE END OF THE GUIDEWIRE WAS BENT AND GOT CAUGHT ON THE END OF THE NEEDLE WHEN TRYING TO EXTRACT IT. THANKFULLY I WAS TRYING TO DO SO AFTER THE WIRE AND NEEDLE HAD BEEN PULLED OUT OF THE PATIENT¿S ARM.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052874 ↗
• MalfunctionSep 28, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "CUSTOMER CALLED IN AND STATED THAT THIS WAS IN REGARDS A GUIDE WIRE THAT SHEERED BROKE." ADDITIONAL INFORMATION RECEIVED 09/22/2021: IT WAS REPORTED THIS PRODUCT WAS ATTEMPTED TO BE USED ON A PATIENT, HOWEVER, IT SHEARED AFTER BEING PULLED FROM THE PATIENT AFTER MEETING RESISTANCE DURING PLACEMENT. NO HARM TO THE PATIENT WAS DONE. THE STAT LOCK DEVICES ARE USED AFTER PLACEMENT FOR SECUREMENT, HOWEVER, AS STATED BEFORE THE WIRE WAS REMOVED DUE TO RESISTANCE MET DURING PLACEMENT. AFTER INSERTING WIRE THROUGH NEEDLE, WIRE BECAME STUCK. UNABLE TO ADVANCE OR RETRACT. REMOVED WIRE AND NEEDLE FROM PATIENT, PULLED VERY HARD ON WIRE AND WIRE SHEARED. NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541833 ↗
• MalfunctionFeb 23, 2017Material Integrity Problem

  ON (B)(6) 2017- PER SALES REP, THE FACILITY REPORTED THAT THE MICROINTRODUCER DID NOT COMPLETELY PEEL AWAY AND A SMALL PORTION WAS LEFT AROUND THE PICC. IT WAS STATED THAT THE USER HAD TO REMOVE THE REMAINING SIDE OF THE MICROINTRODUCER BY PULLING IT AWAY FROM AROUND THE PICC WITH A HEMOSTAT.

  Patient problems: No Information

  MAUDE report 6353307 ↗
• MalfunctionOct 20, 2016Unraveled Material; Physical Resistance; Difficult to Advance

  ON 09/27/2016- PER MEDWATCH, THE FACILITY REPORTED "ATTEMPTED TO PLACE PICC IN RIGHT BASILICA VEIN, OBTAINED ACCESS BUT UNABLE TO THREAD WIRE. WHILE REMOVING WIRE, RESISTANCE WAS MET. UPON TOTAL REMOVAL OF WIRE, NOTED TO HAVE UNRAVELED AND COPPER TIP VISUALIZED. ORDER FOR RIGHT ARM X-RAY OBTAINED." NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6045415 ↗
• MalfunctionApr 1, 2016Coiled; Physical Resistance

  ON (B)(4) 2016 - AS REPORTED BY SALES REPRESENTATIVE, A GUIDEWIRE BECAME "FULLY COILED." THE FACILITY ALLEGED THAT THE GUIDEWIRE FOR THE PICC HAD A SMALL BUMP AT THE DISTAL TIP OF THE GUIDEWIRE TWO INCHES FROM THE END WHERE THE INTRODUCER IS PLACED. ON (B)(4) 2016 - AS REPORTED BY COMPLAINANT - ATTEMPTED TO PULL GUIDEWIRE THROUGH THE NEEDLE, MET RESISTANCE, AND THEN PULLED THE NEEDLE AND GUIDEWIRE OUT TOGETHER. THEY STATED THAT THE WIRE CAME OUT COILED. PRESSURE HELD AT BEDSIDE, AND DOCTOR WAS CALLED TO ASSESS. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5542653 ↗