AccuCath Ace AC1181250Recalls & reported problems
Bard Access Systems, Inc. · AccuCath ACE 18G 1.25”, Basic Kit · Class 2
All models of AccuCath Ace (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741137914), received between Nov 22, 2024 and May 5, 2026 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Problem2
- Defective Component1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2026Activation Problem
IT WAS REPORTED BY CUSTOMER THAT ACCUCATH ACE DEVICE FAILED TO RETRACT THE NEEDLE WHEN THE BUTTON WAS DEPRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088902 ↗MalfunctionApr 1, 2026Activation Problem
IT WAS REPORTED THAT THE NEEDLE WAS BENT COMING OUT OF THE PACKAGE AND THEN COULD NOT RETRACT THE NEEDLE. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758833 ↗MalfunctionNov 22, 2024Material Frayed; Defective Component; Material Frayed; Defective Component
IT WAS REPORTED BY CUSTOMER THAT GUIDEWIRE WENT IN OKAY UNTIL WE GOT TO THE END AND MET A LITTLE RESISTANCE. WE BACKED THE WIRE OUT TO REDIRECT BACK INTO VESSEL. WIRE SEEMED TO PULL BACK SMOOTHLY BUT THEN WHEN WE TRIED TO THREAD THE WIRE AGAIN IT WOULDN'T GO THROUGH AND GOT STUCK ON THE TRACK. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20762431 ↗
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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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