MicroEZ IntroducerRecalls & reported problems across all models

We found 12 models of MicroEZ Introducer by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jan 29, 2016 and May 5, 2026 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MicroEZ Introducer problems

MicroEZ Introducer models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MicroEZ Introducer 0678950

  INTRODUCER, CATHETER
  7 reports
• MicroEZ Introducer 0928945

  INTRODUCER, CATHETER
  3 reports
• MicroEZ Introducer 0678935

  INTRODUCER, CATHETER
  2 reports
• MicroEZ Introducer 0678945

  INTRODUCER, CATHETER
  2 reports
• MicroEZ Introducer 0738945

  INTRODUCER, CATHETER
  2 reports
• MicroEZ Introducer 0228945

  INTRODUCER, CATHETER
  1 report
• MicroEZ Introducer 0688950

  INTRODUCER, CATHETER
  1 report
• MicroEZ Introducer 0828935

  INTRODUCER, CATHETER
  1 report
• MicroEZ Introducer 0928950

  INTRODUCER, CATHETER
  1 report
• MicroEZ Introducer 0738935

  INTRODUCER, CATHETER
  1 report
• MicroEZ Introducer 0738950

  INTRODUCER, CATHETER
  1 report
• MicroEZ Introducer 0828945

  INTRODUCER, CATHETER
  1 report

Recent MicroEZ Introducer adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionDec 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY MEDWATCH MICROINTRODUCER FAILED AT AREA WHERE IT TAPERS ONTO STYLET. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767595 ↗
• MalfunctionOct 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT DILATOR WAS BUCKLING AT THE SKIN EVEN WITH A NICK AT THE SITE, CAUSING THE GRAY PART TO PUSH BACK AND CRUMBLE. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413538 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT NINE PICC KIT INTRODUCER HAD ISSUES WITH DIFFICULT INSERTION. NO OTHER INFORMATION WAS PROVIDED. 09/12/2024: NINE 5FR MICROEZ MICROINTRODUCERS WERE RETURNED FOR EVALUATION, IT WAS FOUND DURING AN INVESTIGATION THERE FIVE OF THE MICROINTRODUCERS HAD DEFORMATION OF THE SHEATH. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20430012 ↗
• 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 ↗
• 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 ↗
• 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 29, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "THE WIRE FROM THE INTRODUCER KIT THEY OPENED UNRAVELED AFTER PULLING IT OUT OF THE PATIENT DURING AN UNSUCCESSFUL PICC INSERTION." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550390 ↗
• 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 ↗
• MalfunctionDec 7, 2018Material Deformation

  IT WAS REPORTED THAT THE GUIDEWIRE WAS TIED IN A KNOT AT THE TIP. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8142035 ↗
• InjuryMar 7, 2018Break; Migration or Expulsion of Device; Difficult to Remove

  IT WAS REPORTED BY THE FACILITY THAT THE LINE WAS PLACED SOME TIME IN (B)(6) 2017 AND A PIECE OF THE GUIDEWIRE BROKE OFF DURING THE PROCEDURE. IT WAS STATED THE MIGRATED SECTION HAS NOT BEEN REMOVED FROM THE PATIENT. NO OTHER INFORMATION AS BEEN PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7322488 ↗

Other Bard Access Systems, Inc. products

• Port Access Needle122 models · 3,744 reports · 3 recalls
• Groshong NXT ClearVue Catheter8 models · 3,266 reports
• PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
• Site~Rite 8 Ultrasound System11 models · 1,965 reports
• PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
• PowerPICC Provena116 models · 1,337 reports · 2 recalls
• PowerPort M.R.I., Groshong10 models · 1,285 reports
• Navarre15 models · 1,228 reports