Peripheral Catheter Insertion Kit AC0202252Recalls & reported problems
Bard Access Systems, Inc. · 20Ga, AccuCath IV Catheter, 2.25”, Intermediate · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741111006), received between Apr 25, 2019 and Oct 18, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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.
Reports received per month
Most reported problems
Device problems
- Defective Component2
- Material Deformation2
- Activation Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2024Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER, THE WIRE CURLED IN ON ITSELF AFTER MEETING RESISTANCE AND LOCKED UP WITH NO WAY TO ADVANCE ANYMORE TO THREAD THE CATHETER. THERE WAS NO ADVERSE OR SERIOUS INJURY TO PATIENT OR HEALTHCARE PROFESSIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20487247 ↗MalfunctionJan 4, 2023Defective Component; Defective Component
IT WAS REPORTED BY THE CUSTOMER "ACCUCATH WIRE WAS REPORTED STUCK. MORE DETAILS NEEDED TO DETERMINE PRODUCT OR USER ERROR. NO ADDITIONAL DETAILS RECEIVED ABOUT PROCEDURE AND OCCURRENCE". ADDITIONAL INFORMATION 12/20/222: PRODUCT WAS USED ON THE PATIENT; PATIENT HAD THE GUIDEWIRE AND CATHETER STUCK IN HER SKIN FOR CLOSE TO 30 MINS UNTIL PROVIDER WAS ABLE TO PULL IT OUT. IV RN COULD NOT RETRACT THE WIRE. RELEVANT HISTORY, PATIENT WAS CONSIDERED DIFFICULT ACCESS. PATIENT DID NOT HAVE AN INFECTIOUS DISEASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16098539 ↗MalfunctionFeb 25, 2022Activation Problem; Activation Problem
IT WAS REPORTED "NEEDLE WOULD NOT SAFETY." ADDITIONAL INFO. RECEIVED (B)(6) 2022: ACCUCATH PLACED WITHOUT DIFFICULTY, WHEN BUTTON DEPRESSED TO SAFETY NEEDLE, IT WOULD NOT RETRACT. BUTTON WAS FULLY DEPRESSED. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13599088 ↗MalfunctionSep 17, 2021Break; Defective Component; Break; Defective Component
IT WAS REPORTED "HAD A NURSE USING THE BELOW ACCUCATH AND THERE WAS A FAILURE DURING INSERTION AND NEARLY A FOREIGN BODY (PIECE OF THE CATHETER) LEFT IN THE PATIENTS ARM." ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED "WAS NOT PLACED, PLACEMENT WAS ATTEMPTED, CATHETER WAS REMOVED AS RN COULD NOT THREAD GUIDE WIRE."
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 12492527 ↗MalfunctionApr 25, 2019Material Deformation
IT WAS REPORTED THAT THAT ONE OF THE ACCUCATH ULTRASOUND IV SETS HAD A KINK IN THE TUBING AND IT WAS UNABLE TO BE USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8551791 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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