Peripheral Catheter Insertion Kit AC0182252Recalls & reported problems
Bard Access Systems, Inc. · 18Ga, AccuCath IV Catheter, 2.25”, Intermediate · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741110993), received between Mar 4, 2020 and Oct 25, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Problem2
- Retraction Problem2
- Detachment of Device or Device Component1
- Material Deformation1
- Material Frayed1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2024Material Frayed; Material Frayed
IT WAS REPORTED PER MEDWATCH, PRESENT ON ADMISSIONS PERIPHERAL INTRAVENOUS LINE IN LEFT UPPER ARM APPEARED TO BE LEAKING AND POSSIBLY INFILTRATED. ULTRASOUND PUT TO ARM BY RN TO SEE IF VEIN WAS STILL PATENT OR IF THE LINE HAD INFILTRATED; WHILE DOT PRESENT THROUGHOUT THE VESSEL WHEN SCANNING - LINE REMOVED, AND GUIDEWIRE STILL PRESENT IN ACCUCATH CATHETER (CURLED TIP INTACT). CATHETER PLACED 09/25. NO INTERVENTION WAS NEEDED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20530345 ↗MalfunctionOct 20, 2024Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE DID NOT RETRACT WHEN ACTIVATED BY PUSH BUTTON SAFETY MECHANISM. NO ADVERSE OR SERIOUS INJURY WAS REPORTED TO THE PATIENT OR THE HEALTHCARE PROFESSIONAL. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20490076 ↗MalfunctionJan 4, 2021Retraction Problem
IT WAS REPORTED VIA MEDWATCH "SAFETY DEVICE TO AUTOMATICALLY RETRACT THE NEEDLE FAILED, NEEDLE WAS LEFT EXPOSED PLACING PATIENT AND STAFF AT RISK FOR POSSIBLE NEEDLESTICK AND EXPOSURE."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11109138 ↗MalfunctionNov 25, 2020Retraction Problem
IT WAS REPORTED INSERTER PLACED ACCUCATH LOT # REEP4055 AND UPON INSERTION, NEEDLE WOULD NOT RETRACT LEAVING NEEDLE EXPOSED. NO OTHER DETAILS WERE GIVEN. HOSPITAL STAFF TO BE RETRAINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10907329 ↗MalfunctionAug 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED PATIENT HAD AN ULTRASOUND GUIDED 18 GAUGE ACCUCATH IV PLACED INTO RIGHT UPPER ARM. ONCE PLACED, IT WOULD NOT DRAW BACK OR FLUSH. IT WAS CORRECTLY PLACED AND VERIFIED WITH ULTRASOUND. THE IV WAS REMOVED. ONCE REMOVED, MD TRIED TO FLUSH FREELY THROUGH THE CATHETER AND J LOOP. THERE WAS QUITE A BIT OF RESISTANCE AND WAS ALSO UNABLE TO DRAW BACK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10434458 ↗MalfunctionMar 4, 2020Material Deformation; Activation Problem; Material Deformation; Activation Problem
IT WAS REPORTED THAT WIRE WOULD NOT THREAD AND WHEN THEY WENT TO RETRACT THE NEEDLE, THE NEEDLE WOULDN¿T RETRACT. THE RN STATED THE WIRE DID THREAD, BUT WHEN CATHETER WAS ADVANCED AND PRESSED THE SAFETY BUTTON, IT WOULD NOT RETRACT. NEEDLE RETRACTED ONCE IT WAS PULLED OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9788247 ↗
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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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