AccuCath Ace AC1201250Recalls & reported problems
Bard Access Systems, Inc. · AccuCath ACE 20G 1.25”, Basic Kit · Class 2
All models of AccuCath Ace (10)
Data updated Oct 16, 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 00801741137921), received between May 22, 2024 and May 22, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (3 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 Problem3
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 22, 2024Activation Problem; Activation Problem
IT WAS REPORTED BY CUSTOMER "THE NEEDLE DOES NOT RETRACT WITH THE BUTTON SO YOU HAVE TO REMOVE FROM PATIENT WITH NEEDLE OUT AND WIRE OUT THEN WHEN YOU TRY TO PULL BACK WIRE OUTSIDE OF PATIENT THE NEEDLE ENDS UP RETRACTING AND PULLING THE WIRE OVER." NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372285 ↗MalfunctionMay 22, 2024Activation Problem; Activation Problem
IT WAS REPORTED BY CUSTOMER "THE NEEDLE DOES NOT RETRACT WITH THE BUTTON SO YOU HAVE TO REMOVE FROM PATIENT WITH NEEDLE OUT AND WIRE OUT THEN WHEN YOU TRY TO PULL BACK WIRE OUTSIDE OF PATIENT THE NEEDLE ENDS UP RETRACTING AND PULLING THE WIRE OVER." NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372258 ↗MalfunctionMay 22, 2024Activation Problem; Activation Problem
IT WAS REPORTED BY CUSTOMER "THE NEEDLE DOES NOT RETRACT WITH THE BUTTON SO YOU HAVE TO REMOVE FROM PATIENT WITH NEEDLE OUT AND WIRE OUT THEN WHEN YOU TRY TO PULL BACK WIRE OUTSIDE OF PATIENT THE NEEDLE ENDS UP RETRACTING AND PULLING THE WIRE OVER." NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372225 ↗
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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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