BD Prevue II Peripheral Vascular Access System 9770700Recalls & reported problems
Bard Access Systems, Inc. · BD Prevue II Console · 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 console is an ultrasound system used to guide needle placement and vascular access procedures. Most of the 63 reports describe unclear or poor-quality images, and some mention the unit freezing, failing to start, or shutting down mid-procedure. None of the reports describe any patient harm. 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
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00801741214912), received between May 5, 2023 and Mar 23, 2026 — classified as 59 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (41 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 Image41
- No Apparent Adverse Event24
- Application Program Freezes or Fails to Launch13
- Defective Component5
- Material Deformation1
- No Display/Image1
- Product Quality Problem1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions59
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026Application Program Freezes or Fails to Launch
IT WAS REPORTED UNIT FROZE DURING PROCEDURE. UNIT IS RUNNING ON SOFTWARE VERSION 1.1.0, SENDING UPDATE DRIVE TO SEE IF THE PROBLEM CONTINUES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24669266 ↗MalfunctionJan 20, 2026Product Quality Problem
IT WAS REPORTED THE PREVUE HAS A RATTLING NOISE, AS IF THERE IS A LOOSE PART. 1/16/2026 - DURING EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE SCANNER DISPLAYED INTERFERENCE IN THE ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24121727 ↗MalfunctionAug 27, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE UNIT IS GIVING SEVERAL BLACK AREAS ON THE IMAGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903808 ↗MalfunctionAug 26, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED VIA STUDY/SURVEY: SCREEN FROZE AND DEVICE BECAME UNRESPONSIVE JUST PRIOR TO THE START OF THE PROCEDURE. THE DEVICE WAS RESET AND FUNCTIONED NORMALLY AFTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893661 ↗MalfunctionAug 12, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE UNIT HAS HORIZONTAL LINES IN THE IMAGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790532 ↗MalfunctionAug 12, 2025Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
IT WAS REPORTED THAT THE SCREEN IS NOT CLEAR, "BLACK STRIP HANGING FROM BACK COVER". NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790437 ↗MalfunctionJul 23, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY A TM THAT THE SCREEN IS REALLY DIM. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22583835 ↗MalfunctionJul 16, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED IMAGES ON SCANNER ARE UNCLEAR. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523970 ↗MalfunctionJul 1, 2025Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
IT WAS REPORTED BY CLINICAL SPECIALIST, AFTER 1 MINUTE AND 50 SECONDS (CONSISTENTLY - REPLICATED MULTIPLE TIMES), THE SCREEN GOES FROM ULTRASOUND WORKING TO FREEZE WITH THE TOP PART OF SCREEN DARKENED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378349 ↗MalfunctionJun 20, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BY A TM THE FACILITY IS UNHAPPY WITH THE IMAGE QUALITY AND NO LONGER USE THE ULTRASOUND. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22301622 ↗MalfunctionJun 19, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BY A TM THE FACILITY IS UNHAPPY WITH THE IMAGE QUALITY AND NO LONGER USE THE ULTRASOUND. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292534 ↗MalfunctionApr 30, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE ARE LINES ON THE IMAGES. THE PROBE PASSED THE ASSESSMENT TEST. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21939744 ↗MalfunctionApr 30, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED BY A TM THAT WHILE SETTING UP FOR THE PROCEDURE, THE MACHINE FROZE AND BECAME UNRESPONSIVE TO TOUCH AND WOULD NOT SCAN. A SECOND OPERATOR WAS PRESENT WHO TURNED THE MACHINE OFF AND BACK ON, THEN THE MACHINE FUNCTIONED NORMALLY. NO PATIENT HARM CAME OF THIS EVENT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21939738 ↗MalfunctionApr 25, 2025Poor Quality Image; Poor Quality Image
OBSERVATION FOUND DURING EVALUATION AT BD SERVICE CENTER: THERE ARE HORIZONTAL LINES IN THE ULTRASOUND IMAGE DUE TO INTERFERENCE WITHIN THE RFID ANTENNA. THIS IS DUE TO AN INTERNAL FAILURE WITHIN THE RFID ANTENNA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21910077 ↗MalfunctionApr 24, 2025Poor Quality Image; Poor Quality Image
OBSERVATION FOUND DURING EVALUATION AT BD SERVICE CENTER: THE PREVUE II DISPLAYS WHITE HORIZONTAL LINES IN THE ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21904639 ↗MalfunctionMar 31, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE IS A DARK LINE RUNNING DOWN THE SCREEN MAKING IT DIFFICULT TO PLACE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21730748 ↗MalfunctionFeb 12, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED ISSUES OF INTERFERENCE WERE OCCURRING DESPITE BEING REMOVED FROM AREAS THAT WOULD CAUSE INTERFERENCE. CUE INTERFACE CONTINUED TO DROP OFF THE SCREEN CAUSING THE NURSES NOT TO BE ABLE TO USE CUE TO PROPERLY ACCESS VEINS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21365243 ↗MalfunctionFeb 6, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE IS A DARK SHADOW ON THE DISPLAY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21329319 ↗MalfunctionJan 9, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED, UNIT IS EXPERIENCING IMAGE ARTIFACT ISSUES/WHITE LINES IN THE IMAGES WHEN USING THE DEVICE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21120434 ↗MalfunctionDec 29, 2024Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BY THE CUSTOMER "WE HAVE NOTICED SOME BLURRINESS IN THE IMAGES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21032710 ↗MalfunctionNov 26, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED, THE SYSTEM IS BRAND NEW BUT IT CONTINUES TO FREEZE DURING INSERTIONS. THEY HAVE HAD 3 INSERTIONS WHERE THE SYSTEM IS FROZEN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20783148 ↗MalfunctionNov 14, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED BY THE CUSTOMER, SYSTEM IS INTERMITTENTLY LOSING CONNECTION AND FREEZING WHILE USING THE CUE OPTION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20682873 ↗MalfunctionNov 8, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CUSTOMER'S PREVUE II HAS INTERMITTENT FUZZINESS WHEN SCANNING PATIENTS. THE PROBE IS ALSO INTERMITTENTLY, THROWING AN ERROR CODE THAT LOCKS UP THE SCREEN/INTERFERES WITH PROBE/SCANNER COMMUNICATION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20646461 ↗MalfunctionOct 28, 2024Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BY A TM - IMAGE IS TERRIBLE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20549753 ↗MalfunctionOct 9, 2024Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE IMAGE DOES NOT PROVIDE ADEQUATE VISUALIZATION OF THE VESSEL IN ORDER TO PLACE CATHETER. USING THIS MACHINE IS LEADING TO INTERRUPTIONS IN PATIENT CARE AND PATIENT SAFETY CONCERNS. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410019 ↗
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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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