AccuCath Ace PCK00010Recalls & reported problems
Bard Access Systems, Inc. · Catheter Placement Kit · Class 2
All models of AccuCath Ace (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741223693), received between May 13, 2026 and May 13, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Problem” (1 report).
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 Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Activation Problem
IT WAS REPORTED ISSUE WHILE PLACING AN ULTRASOUND GUIDED LINE USING 20G ACCUCATH. ACCUCATH GUIDEWIRE ADVANCED, CATHETER SLID OVER ACCUCATH GUIDEWIRE WITHOUT ISSUE. THE NEEDLE BUTTON WOULD NOT COMPRESS TO INITIATE NEEDLE RETRACTION FOR THE NEEDLE SAFETY. ULTRASOUND LINE ALMOST BECAME DISLODGED. NEEDLE WAS THEN MANUALLY PULLED OUT AND PLACED IN SHARPS BIN. THERE WAS NO BEND OR FLEX IN THE NEEDLE DURING INSERTION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162104 ↗
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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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