BD Prevue II Peripheral Vascular Access System 9770703Recalls & reported problems
Bard Access Systems, Inc. · BD Prevue II Traditional Probe · Class 2
All models of BD Prevue II Peripheral Vascular Access System (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Prevue II imaging probe is used for peripheral vascular access. Its 98 adverse event reports include no deaths, no injuries and 98 malfunctions. The reports mostly describe poor or very dark images, with some noting dark spots or a bubble blocking part of the picture. Several reports say there was no patient impact. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 93
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00801741214950), received between Apr 21, 2023 and May 29, 2026 — classified as 93 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (69 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
- Poor Quality Image69
- Defective Component25
- No Apparent Adverse Event8
- Break7
- Product Quality Problem7
- Imprecision1
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions93
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Poor Quality Image
IT WAS REPORTED THAT PROBE IS GIVING VERY DARK IMAGES. TRIED PROBE ON 3 DIFFERENT CONSOLES, ISSUE FOLLOWED THE PROBE. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333465 ↗MalfunctionMay 5, 2026Poor Quality Image
IT WAS REPORTED THAT DEVICE HAD POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088905 ↗MalfunctionMay 4, 2026Poor Quality Image
IT WAS REPORTED THAT THE DEVICE HAS POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25069317 ↗MalfunctionApr 22, 2026Product Quality Problem
IT WAS REPORTED THAT PROBE FAILED ELEMENT TEST. (B)(6) 2026 IT WAS FOUND DURING AN INVESTIGATION THERE IS A DARK SPOT IN THE IMAGE DUE TO THE ELEMENT FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954291 ↗MalfunctionMar 24, 2026Poor Quality Image
IT WAS FOUND DURING EVALUATION AT BD SERVICE CENTER: THE PROBE ASSESSMENT TEST DISPLAYED VARYING NUMBERS FROM 1 TO UP TO 4 RED "X'S" INDICATING TRANSDUCER ELEMENT FAILURE. NUMEROUS TESTS WERE RUN TO VERIFY THESE FAILURES. THE ULTRASOUND IMAGE THAT DISPLAYS FROM THIS PROBE IS VERY DARK. THIS ISSUE IS INTERMITTENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24676962 ↗MalfunctionMar 18, 2026Poor Quality Image
IT WAS REPORTED UNIT WAS DROPPED AND NOW HAS IMAGE ISSUES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629780 ↗MalfunctionMar 10, 2026Product Quality Problem
IT WAS REPORTED PROBE IS FAILING ASSESSMENT TEST. NO FURTHER INFORMATION WAS PROVIDED. 6 MARCH 2026 EVALUATION FOUND ELEMENT FAILURE RESULTED IN A DARK AREA ON THE RIGHT SIDE OF THE ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24563155 ↗MalfunctionMar 9, 2026Poor Quality Image
IT WAS REPORTED PROBE IS GIVING NOISE IN IMAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547662 ↗MalfunctionMar 2, 2026Poor Quality Image
IT WAS REPORTED CUSTOMER HAVING NOISE ISSUES ON THEIR PREVUE II. THEY TRIED MULTIPLE PROBES; ALL HAVING THE SAME ISSUE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24490042 ↗MalfunctionFeb 27, 2026Break
IT WAS REPORTED THAT THE CORD HAS BEEN COMPLETELY PULLED OUT AT THE STRAIN RELIEF/EXPOSING WIRING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474228 ↗MalfunctionFeb 19, 2026Poor Quality Image
IT WAS REPORTED SHADOWS ON THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24397169 ↗MalfunctionFeb 5, 2026Poor Quality Image; Product Quality Problem
IT WAS REPORTED THE PROBE IS GIVING BLACK LINES ON IMAGES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273745 ↗MalfunctionFeb 5, 2026Poor Quality Image; Product Quality Problem
IT WAS REPORTED THE PROBE IS GIVING BLACK LINES ON IMAGES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273456 ↗MalfunctionJan 27, 2026Poor Quality Image
IT WAS REPORTED THE IMAGE IS EXTREMELY BLURRY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24195524 ↗MalfunctionJan 27, 2026Poor Quality Image
IT WAS REPORTED THE PROBE IS SHOWING ARTIFACTS AND BLACK LINES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193767 ↗MalfunctionJan 20, 2026Product Quality Problem
IT WAS REPORTED THE PROBE IS FAILING THE ASSESSMENT TEST. 1/16/2026 - DURING EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THE PROBE DISPLAYS A DARK SPOT ON THE RIGHT SIDE OF THE ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24121719 ↗MalfunctionDec 22, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED OF VISIBLE DAMAGE ON THE HEAD OF THE PROBE IMPACTING IMAGE QUALITY ON PREVUE 2. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23866498 ↗MalfunctionDec 22, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE PROBE HAS DARK VERTICAL SHADOWS IN THE IMAGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23866491 ↗MalfunctionDec 22, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE PROBE IS GIVING POOR QUALITY IMAGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865301 ↗MalfunctionDec 9, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE PROBE IS GIVING GRAY AND WHITE LINES ON THE SCREEN WHEN PLUGGED IN. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23763971 ↗MalfunctionDec 2, 2025Poor Quality Image; Product Quality Problem; Poor Quality Image; Product Quality Problem
IT WAS REPORTED TORN STRAIN RELIEF. 11/12/2025 IT WAS FOUND DURING AN INVESTIGATION THERE IS A TEAR IN THE PROBE¿S TRANSDUCER PAD, CAUSING A DARK IMAGE ON THE RIGHT SIDE OF THE ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696394 ↗MalfunctionNov 19, 2025Poor Quality Image; Product Quality Problem; Poor Quality Image; Product Quality Problem
IT WAS REPORTED THE IMAGE IS FUZZY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23595612 ↗MalfunctionOct 30, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE ARE HORIZONTAL LINES WHEN USING THIS PROBE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23423894 ↗MalfunctionOct 21, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY THE CUSTOMER "A PORTION IS NOT DISPLAYING AN IMAGE, LOOKS LIKE AN AIR BUBBLE TRAPPED IN THE TIP OF THE PROBE BECAUSE I CAN MOVE THE IMAGE VOID BY APPLYING SLIGHT PRESSURE ON THE FACE OF THE PROBE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350489 ↗MalfunctionOct 21, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY THE CUSTOMER, THERE ARE WHITE SPECKLES ON IMAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350487 ↗
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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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