Peripheral Catheter Insertion Kit AC0182250Recalls & reported problems
Bard Access Systems, Inc. · 18Ga, AccuCath IV Catheter, 2.25”, Basic · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Bard AccuCath IV catheter kit, a short-term peripheral IV placed in a vein for infusions. The 50 reports mostly describe the catheter breaking, the needle failing to retract, parts disconnecting, and fluid leaking out of the vein (extravasation). Three reports describe injuries, including a guidewire tip shearing off and staying in a patient's arm. There were no deaths and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00801741110931), received between Dec 6, 2016 and May 6, 2022 — classified as 3 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Break” (7 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 18, 2026.
Most reported problems
Device problems
- Break7
- Retraction Problem6
- Activation Problem5
- Defective Component5
- Disconnection5
- Bent4
- Fluid/Blood Leak4
- Physical Resistance/Sticking4
Patient problems
- No Known Impact Or Consequence To Patient25
- No Consequences Or Impact To Patient8
- Extravasation4
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient2
- Injury2
- No Information2
- Foreign Body Reaction1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "CUSTOMER HAS HAD 4 18G ACCUCATHS EXTRAVASATE OVER THE PAST COUPLE OF DAYS." THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: Extravasation
MAUDE report 14311758 ↗MalfunctionMay 6, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "CUSTOMER HAS HAD 4 18G ACCUCATHS EXTRAVASATE OVER THE PAST COUPLE OF DAYS." THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Extravasation
MAUDE report 14311731 ↗MalfunctionMay 6, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "CUSTOMER HAS HAD 4 18G ACCUCATHS EXTRAVASATE OVER THE PAST COUPLE OF DAYS." THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: Extravasation
MAUDE report 14311693 ↗MalfunctionMay 6, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "CUSTOMER HAS HAD 4 18G ACCUCATHS EXTRAVASATE OVER THE PAST COUPLE OF DAYS." THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: Extravasation
MAUDE report 14311685 ↗InjuryMar 18, 2022Material Frayed; Material Frayed
IT WAS REPORTED VIA MEDWATCH " ULTRASOUND GUIDED IV IN THE UPPER R ARM OF THE PATIENT. THE IV HAS AN INTERNAL GUIDEWIRE, THE TIP OF THE GUIDEWIRE WAS CAUGHT IN SUBCUTANEOUS TISSUES AND SHEARED OFF THE IV, REMAINING IN THE PATIENT'S ARM."
Patient problems: Foreign Body In Patient
MAUDE report 13804185 ↗MalfunctionAug 4, 2021Defective Component; Activation Problem; Defective Component; Activation Problem
IT WAS REPORTED THAT THE WIRE DID NOT THREAD AS INTENDED. IT ADVANCED UPWARD AND NEEDLE DID NOT RETRACT 100%. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12274965 ↗MalfunctionJan 15, 2021Retraction Problem
IT WAS REPORTED THAT THE CATHETER COULD NOT SLIDE OFF THE NEEDLE AND THE NEEDLE WOULD NOT RETRACT. FACILITY CONCERNED THIS WAS DUE TO BURRS ON THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.
MAUDE report 11178355 ↗MalfunctionDec 16, 2020Flushing Problem
IT WAS REPORTED THE ACCUCATH WOULDN'T FLUSH. THE CATHETER WAS REMOVED, HEALTH CARE PROFESSIONAL EXPECTING TO SEE A KINK BUT THERE WERE NO DEFICIENCIES NOTICED, BUT CONCERNED THE ACCUCATH AND EXTENSION BOTH MALFUNCTIONED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11023785 ↗MalfunctionOct 9, 2020Retraction Problem; Mechanical Jam
IT WAS REPORTED VIA MEDWATCH "GUIDEWIRE APPEARS TO BE STUCK. UNABLE TO RETRACT NEEDLE AND PUSH GUIDEWIRE IN." ORIGINAL PROCEDURE: "INSERTION OF ULTRASOUND GUIDED INTRAVENOUS NEEDLE INTO A DIFFICULT ACCESS PATIENT."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10659002 ↗MalfunctionSep 24, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING INSERTION, THE WIRE WOULDN'T ADVANCE. A NEW DEVICE WAS PLACED. ADDITIONAL INFORMATION RECEIVED 8/21/2020: IT WAS REPORTED THE PICC WAS PLACED IN THE LEFT BASILIC VEIN IN THE UPPER ARM. THERE WAS NO PATIENT HARM OR ANY EXTENSIVE TISSUE DAMAGED. IT WAS DETERMINED THAT THE RETURNED DEVICE WAS FOUND KINKED DURING EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10581316 ↗MalfunctionSep 10, 2020Physical Resistance/Sticking
PER NURSE, "GUIDEWIRE APPEARS TO BE STUCK. UNABLE TO RETRACT NEEDLE AND PUSH GUIDEWIRE IN". MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS, PERIPHERAL CATHETER INSERTION KIT (PER SITE REPORTER). ALERTED THE BD REP FOR THE FACILITY THAT THERE WAS AN ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10514074 ↗MalfunctionJul 15, 2020Defective Component; Defective Component
IT WAS REPORTED: ¿PRIOR TO STICKING THE PATIENT THE WIRE DID GO SMOOTHLY. ONCE THE NURSE HAD ACCESS THE WIRE WOULD NOT ADVANCE (THIS WAS HUGE VEIN AND I (THE NURSE) HAD A SOLID BULL'S EYE AND WALKED THE NEEDLE THROUGH AS NORMAL SO I AM 100% POSITIVE I WAS IN THE RIGHT PLACE). AFTER THE WIRE WOULDN'T ADVANCE THE NURSE ATTEMPTED TO RETRACT THE NEEDLE SINCE THE NURSE DIDN'T FEEL COMFORTABLE LEAVING THE LINE IN THIS VEIN HAVING NOT ADVANCED THE WIRE. THE NEEDLE WOULD NOT RETRACT AND FELT STUCK IN THE CATHETER WHEN THE NURSE PULLED IT OUT. THERE WAS NO LOOP WHEN IT CAME OUT OF THE PATIENT. THE NURSE WAS LOOKING AT THE NEEDLE TRYING TO FIGURE OUT WHAT HAPPENED AND ATTEMPTED TO GET THE NEEDLE TO RETRACT OR GET MOVEMENT FROM THE WIRE AT ALL. THAT'S HOW THE LOOP HAPPENED. THE NURSE HAS HAD ISSUES BEFORE WITH THE WIRE NOT ADVANCING OR THE NEEDLE NOT RETRACTING BUT NOTHING QUITE LIKE THIS. NO HARM NOTED TO THE PATIENT.¿
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10280084 ↗MalfunctionApr 29, 2020Defective Component; Activation Problem; Defective Component; Activation Problem
IT WAS REPORTED THE GUIDEWIRE OF THE ACCUCATH WAS EXTENDING FROM FLASH PORT, WHICH PREVENTED THE SAFETY MECHANISM FROM FULLY ENGAGING/COVERING NEEDLE TIP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10011473 ↗MalfunctionApr 16, 2020Defective Component; Defective Component
IT WAS REPORTED THAT THE ACCUCATH GUIDE WIRE IS BENDING AND COMING OUT THE SIDE OF THE DEVICE AND IS NOT ALLOWING FULL RETRACT OF THE ACCUCATH NEEDLE. THIS ISSUE IS CAUSING PATIENT VEIN DAMAGE AND SAFETY ISSUES FOR STAFF AND PATIENTS. IT WAS STATED THIS OCCURRED TWICE WITH LOT REDX2355. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Injury
MAUDE report 9969637 ↗MalfunctionApr 16, 2020Defective Component; Defective Component
IT WAS REPORTED THAT THE ACCUCATH GUIDE WIRE IS BENDING AND COMING OUT THE SIDE OF THE DEVICE AND IS NOT ALLOWING FULL RETRACT OF THE ACCUCATH NEEDLE. THIS ISSUE IS CAUSING PATIENT VEIN DAMAGE AND SAFETY ISSUES FOR STAFF AND PATIENTS. IT WAS STATED THIS OCCURRED TWICE WITH LOT REDX2355. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: Injury
MAUDE report 9969627 ↗MalfunctionOct 1, 2019Material Deformation; Material Deformation
IT WAS REPORTED VIA MEDWATCH REPORT "AFTER AN UNSUCCESSFUL ATTEMPT TO FLUSH THE PATIENT'S IV ACCESS, THE CATHETER WAS REMOVED AND NOTED TO HAVE A VERY OBVIOUS KINK IN IT."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9142057 ↗MalfunctionSep 19, 2019Material Deformation; Material Deformation
IT WAS REPORTED VIA MEDWATCH "PATIENT'S PERIPHERAL IV UNABLE TO FLUSH DESPITE NUMEROUS ATTEMPTS. PERIPHERAL IV WAS PULLED AND NOTED TO HAVE A KINK IN IT. RECURRING PROBLEM."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9090269 ↗MalfunctionSep 18, 2019Activation Problem; Activation Problem
IT WAS REPORTED THAT THE CATHETER SAFETY BUTTON WAS STUCK DOWN WHEN THE PLACER WENT TO ACTIVATE IT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9084652 ↗MalfunctionSep 18, 2019Activation Problem; Activation Problem
IT WAS REPORTED THAT THE TM WAS AT A FACILITY AND THEY HAD TWO CATHETERS THAT WHEN THEY ACTIVATED THE NEEDLE, IT DID NOT RETRACT. THIS CAUSED THEM TO PULL THE WHOLE THING OUT AND LOSE ACCESS. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9082958 ↗MalfunctionSep 18, 2019Activation Problem; Activation Problem
IT WAS REPORTED THAT THE TM WAS AT A FACILITY AND THEY HAD TWO CATHETERS THAT WHEN THEY ACTIVATED THE NEEDLE, IT DID NOT RETRACT. THIS CAUSED THEM TO PULL THE WHOLE THING OUT AND LOSE ACCESS. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9082955 ↗MalfunctionAug 27, 2019Flushing Problem; Material Twisted/Bent
PATIENT'S PERIPHERAL IV UNABLE TO FLUSH DESPITE NUMEROUS ATTEMPTS. PERIPHERAL IV WAS PULLED AND NOTED TO HAVE A KINK IN IT. RECURRING PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8934762 ↗MalfunctionAug 27, 2019Flushing Problem; Material Twisted/Bent
AFTER AN UNSUCCESSFUL ATTEMPT TO FLUSH THE PATIENT'S IV ACCESS, THE CATHETER WAS REMOVED AND NOTED TO HAVE A VERY OBVIOUS KINK IN IT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8934761 ↗InjuryJun 6, 2019Break
IT WAS REPORTED THAT THE PATIENT HAD ACCUCATH PLACED IN ARM, WHILE IT WAS ALREADY IN ARM, THE CATHETER BROKE OFF INTO PATIENT'S ARM AND COULD NOT BE IDENTIFIED IN THE VEIN UNDER ULTRASOUND. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body Reaction
MAUDE report 8675759 ↗MalfunctionApr 12, 2019Retraction Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THE IV NURSE ATTEMPTING TO PLACE THE DEVICE CLAIMS THAT THE WIRE WOULD NOT DEPLOY AND WHEN HE TRIED TO SAFETY THE CATHETER, THE NEEDLE WOULDN¿T RETRACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8509803 ↗InjuryMar 8, 2019Entrapment of Device; Material Twisted/Bent
IT WAS REPORTED THAT THE CURLED TIP OF THE GUIDEWIRE GOT STUCK ON THE CATHETER TIP AND WHEN ATTEMPTING TO RETRACT THE WIRE, IT MADE THE CATHETER KINK AND CURL UP WHILE STILL INDWELLING IN THE VESSEL. IT IS STATED THE PHYSICIAN HAD TO REMOVE THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8404570 ↗
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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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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