Pinpoint GT Needle Guide Kit 9770691Recalls & reported problems
Bard Access Systems, Inc. · 21G Needle Guide Kit w/ 96" Cover, Shallow · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741109126), received between Oct 25, 2024 and Oct 29, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination 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
- Contamination /Decontamination Problem1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED BY CUSTOMER THAT HUMAN HAIR INSIDE PROBE COVER PACKAGE WHILE PREPARING FOR USE DURING A STERILE PROCEDURE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20559019 ↗MalfunctionOct 25, 2024Defective Component; Defective Component
IT WAS REPORTED BY CUSTOMER THAT FINDING A HOLE IN PROBE COVER FOLLOWING APPLICATION FOR USE DURING STERILE PROCEDURE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20536390 ↗
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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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