BD SiteRite 9 Ultrasound SystemRecalls & reported problems across all models
Bard Access Systems, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 251
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of BD SiteRite 9 Ultrasound System by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 251 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2023 and Sep 30, 2026 — classified as 251 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (143 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD SiteRite 9 Ultrasound System problems
Device problems
- Poor Quality Image143
- No Apparent Adverse Event64
- Application Program Freezes or Fails to Launch38
- Data Problem24
- Defective Component23
- Unexpected Shutdown22
- Difficult or Delayed Activation10
- Product Quality Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions251
BD SiteRite 9 Ultrasound System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD SiteRite 9 Ultrasound System 9770800System, imaging, pulsed echo, ultrasonic172 reports
- BD SiteRite 9 Ultrasound System 9770803Transducer, ultrasonic, diagnostic79 reports
Recent BD SiteRite 9 Ultrasound System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954902 ↗MalfunctionSep 30, 2026Difficult or Delayed Activation
It was reported unit has a 1 second delayed image. No patient impact. Out of box failure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941956 ↗MalfunctionSep 30, 2026No Display/Image
It was reported unable to find the needle tip during midline placement. No patient impact. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941798 ↗MalfunctionSep 23, 2026Data Problem
It was reported the 3CG feature is showing internal reading before inserting the PICC. No patient impact. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870560 ↗MalfunctionSep 23, 2026Poor Quality Image
It was reported the Probe has gone black down the center and there is wear on the strain relief. No patient impact. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870558 ↗MalfunctionSep 22, 2026Data Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853502 ↗MalfunctionJul 20, 2026Poor Quality Image; Product Quality Problem
IT WAS REPORTED PROBE IMAGE DISTORTED, GREYED OUT. POOR IMAGE QUALITY. FAILING PROBE ASSESSMENT TEST AT TIMES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25875630 ↗MalfunctionJun 4, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT USERS ARE COMPLAINING OF LAGGING. SOFTWARE IS UP TO DATE. CUE IS NOT BEING USED AND HAS BEEN TURNED OFF. UNIT WAS JUST IN TO REPAIR USB PORTS. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25402573 ↗MalfunctionMay 12, 2026Poor Quality Image
IT WAS REPORTED BY A TM- IMAGE IS "FUZZY" AND JUMPY, SEEMS TO HAVE A SHADOW. WITH PROBE COVER (ANY PROBE COVER) THE IMAGE BECOMES MORE DISTORTED, CANNOT VISUALIZE NEEDLE TIP. LOOSE CONNECTION TO IPAD. I BELIEVE THEY WERE REFERENCING THE USB CONNECTION FROM THE SHERLOCK TO THE ULTRASOUND MACHINE. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155995 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED CORD IS PULLING AWAY AT THE STRAIN RELIEF, EXPOSING WIRING. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155991 ↗MalfunctionMay 4, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT UNIT HAVING SIGNIFICANT LAG ISSUES WHILE SCANNING. NO ADDITIONAL DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25070013 ↗MalfunctionApr 13, 2026Unexpected Shutdown
IT WAS REPORTED THAT SHUTS DOWN AND DUMPS PHOTOS AT LEAST 1-2 TIMES PER DAY. HOLDS BATTERY BETTER IF PUT TO SLEEP RIGHT AFTER YOU USE IT, BUT IT DOESN'T NECESSARILY SHUT DOWN. NOT TURNING ON LESS OFTEN. EVERY OTHER OR THIRD DAY. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24861042 ↗MalfunctionApr 13, 2026Unexpected Shutdown
IT WAS REPORTED THAT SHUTS DOWN AND DUMPS PHOTOS AT LEAST 1-2 TIMES PER DAY. HOLDS BATTERY BETTER IF PUT TO SLEEP RIGHT AFTER YOU USE IT, BUT IT DOESN'T NECESSARILY SHUT DOWN. NOT TURNING ON LESS OFTEN. EVERY OTHER OR THIRD DAY. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860459 ↗MalfunctionApr 6, 2026Difficult or Delayed Activation
IT WAS REPORTED THE DEVICE IS LAGGING, AND "GOING TO THE LEFT WHEN CENTERED". NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794111 ↗MalfunctionApr 6, 2026Poor Quality Image
IT WAS REPORTED THAT CUSTOMER IS EXPERIENCING DROP OUT ON IMAGES. USED ON A DIFFERENT SCANNER, ISSUE FOLLOWED THE PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790423 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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