VACORA® VB10118USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741079320), received between Apr 5, 2019 and Oct 22, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2020Failure to Calibrate; Device Contamination with Chemical or Other Material; Failure to Calibrate; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VB10118US BIOPSY INSTRUMENT ALLEGEDLY FAILED TO CALIBRATE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE REPORTED MALFUNCTION DID NOT INVOLVE A PATIENT. THE AGE AND WEIGHT OF THE FEMALE PATIENT WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10722924 ↗
• MalfunctionApr 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL VC10118US BIOPSY INSTRUMENT ALLEGEDLY A RED PLASTIC PIECE WAS FOUND ON THE TIP OF THE NEEDLE WHEN OPENING THE PACKAGE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE ONE DID NOT INVOLVED PATIENTS WITH NO REPORTED PATIENT CONTACT. THE PATIENTS AGE AND WEIGHT NOT PROVIDED. OF THE REPORTED PATIENTS WAS FEMALE.

  Patient problems: No Patient Involvement

  MAUDE report 8489070 ↗