AccuCath Ace AC1182252Recalls & reported problems
Bard Access Systems, Inc. · AccuCath ACE 18G 2.25”, Intermediate Kit · Class 2
All models of AccuCath Ace (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741138003), received between Sep 2, 2022 and Mar 25, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (5 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
- Activation Problem5
- Component Incompatible1
- Defective Component1
- Fail-Safe Did Not Operate1
- Material Frayed1
- Material Twisted/Bent1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Pain1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Activation Problem
IT WAS REPORTED WHEN THEY ATTEMPTED TO RETRACT NEEDLE, THE EQUIPMENT WAS FAULTY IN RETRACTING THE NEEDLE. THE BUTTON DEPRESSED, BUT THE NEEDLE DID NOT MOVE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24686035 ↗MalfunctionFeb 19, 2026Product Quality Problem
IT WAS REPORTED VIA MEDWATCH THAT THERE WAS AN ISSUE WITH AN ACCU CATH DURING PATIENT USE. IT WAS REPORTED THAT AN EIGHTEEN GAUGE ACCU CATH HAD DIFFICULTY WITH THE GUIDEWIRE, WHICH APPEARED TO BE PRE DISENGAGING. THE INTRAVENOUS LINE WAS ABLE TO BE PLACED AND THE GUIDEWIRE WAS REMOVED INTACT. NO INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387668 ↗MalfunctionDec 29, 2025Activation Problem; Activation Problem
IT WAS REPORTED VIA MEDSUN THAT NEEDLE RETRACTING MECHANISM WOULD NOT ENGAGE. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919149 ↗MalfunctionDec 11, 2025Fail-Safe Did Not Operate
SAFETY ISSUE WITH GUIDEWIRE IV CATHETER USED TO PLACE PERIPHERAL US [ULTRASOUND] IVS. WHILE INSERTING THE IV IN THE PATIENT, THE NEEDLE RETRACTING MECHANISM WOULD NOT ENGAGE. THE CATHETER ALSO DID NOT OCCLUDE AS IT SHOULD, CAUSING RN TO HAVE TO HOLD PRESSURE WHILE REMOVING THE NEEDLE FROM THE PATIENT'S ARM WHICH INCREASED THE RISK OF NEEDLESTICK. THANKFULLY, ANOTHER RN NEARBY WAS ABLE TO SAFELY REMOVE AND DISCARD THE SHARP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778080 ↗MalfunctionOct 29, 2025Activation Problem; Activation Problem
IT WAS REPORTED ISSUES WITH NEEDLE RETRACTION, LEADING TO ADDITIONAL STICK. THE NEEDLE RETRACTION FAILURE WAS DURING PATIENT USE. THE CATHETER WOULD NOT ADVANCE AND THE CATHETER WAS REMOVED FROM THE PATIENT. WHEN THE NURSE PUSHED THE BUTTON TO RETRACT, ABOUT 1CM OF THE NEEDLE WOULD NOT RETRACT BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420418 ↗MalfunctionMay 22, 2025Component Incompatible; Material Frayed; Component Incompatible; Material Frayed
IT WAS REPORTED THAT THE GUIDEWIRE CAME OUT OF THE SIDE NEEDLE NOTCH. THIS OCCURRED DURING TRAINING USING A VEIN BLOCK, NOT ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22070684 ↗MalfunctionDec 26, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED VIA MEDWATCH THAT WHILE ATTEMPTING TO PLACE AN 18G ACCUCATH IN PATIENT'S LAC, THE ACCUCATH GUIDEWIRE APPEARED TO FISHHOOK AND BECAME LODGED UNDER PATIENT'S SKIN. PA WAS CONTACTED. PA MADE SMALL SKIN NIK AND WIRE WAS REMOVED INTACT. DRESSING OF GAUZE AND TAPE APPLIED. PATIENT TOLERATED WELL. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21023403 ↗MalfunctionMay 9, 2023Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER "RN PLACED ACCUCATH BUT DID SO WITHOUT SAFETY ENGAGING AND WITH GUIDEWIRE NOT BEING ABLE TO DEPLOY. GUIDEWIRE SEEMED TO HAVE GOTTEN STUCK IN NEEDLE AND SPREAD TO THE LEFT FROM ONE OF THE NEEDLE HOLES. PATIENT EXPERIENCED PAIN DURING WITHDRAW OF DEVICE. CATHETER REMAINED IN PLACE."
Patient problems: Pain
MAUDE report 16899127 ↗MalfunctionApr 27, 2023Defective Component; Defective Component
CUSTOMER REPORTED THAT THE GUIDEWIRE MECHANISM IS ROUGH AND MORE DIFFICULT TO DEPLOY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16828573 ↗MalfunctionSep 2, 2022Activation Problem; Activation Problem
IT WAS REPORTED "18G ACCUCATH WAS INSERTED ON PATIENT AND WHEN THE CLINICIAN WENT TO RETRACT THE NEEDLE, SHE PUSHED THE BUTTON, AND NOTHING HAPPENED. THE NEEDLE DID NOT RETRACT. SHE THEN PULLED THE NEEDLE OUT OF THE CATHETER HUB TO SEE IF THAT WOULD HELP THE NEEDLE TO RETRACT. THE NEEDLE STILL DID NOT RETRACT. THE WHITE BUTTON WOULD ACTIVELY CLICK, BUT THE NEEDLE FAILED TO RETRACT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15353179 ↗
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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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