Site-Rite 9770169Recalls & reported problems
Bard Access Systems, Inc. · SITE-RITE VISION II 20MM LINEAR PROBE · Class 2
All models of Site-Rite (20)
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 00801741125348), received between Sep 13, 2018 and Nov 20, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Erratic or Intermittent Display” (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 16, 2026.
Most reported problems
Device problems
- Erratic or Intermittent Display1
- Material Split, Cut or Torn1
- No Display/Image1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2018No Display/Image
PER BIOMED: THE ULTRASOUND SCANS ARE TOO DARK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8092453 ↗MalfunctionSep 21, 2018Erratic or Intermittent Display
SALES REP REPORTED ULTRASOUND SYSTEM'S PROBE PRODUCES POOR IMAGE QUALITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7899571 ↗MalfunctionSep 13, 2018Material Split, Cut or Torn
IT WAS REPORTED BY THE BD SALES REP ON BEHALF OF THE PICC RN THAT THE VISION II ULTRASOUND 20MM LINEAR PROBE STRAIN RELIEF IS TORN. THE IMAGE SENT SHOWS EXPOSED CABLE WIRES AS A RESULT OF THE PHYSICAL DAMAGE.
Patient problems: No Information
MAUDE report 7873266 ↗
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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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