VACORA® VB10118Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741079313), received between May 2, 2017 and Aug 9, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, ONCE THE NEEDLE WAS PLACED, IT ALLEGEDLY DETACHED A SMALL PIECE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17486490 ↗
• MalfunctionApr 5, 2019Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL VB10118 BIOPSY INSTRUMENT ALLEGEDLY MOVED UNEXPECTEDLY. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE ONE EVENTS INVOLVED PATIENTS WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE AND WEIGHT NOT PROVIDED. OF THE REPORTED PATIENTS WAS FEMALE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489069 ↗
• MalfunctionSep 26, 2018Failure to Cycle; Difficult to Remove; Failure to Cycle; Difficult to Remove

  IT WAS REPORTED THAT DURING A BIOPSY OF THE THIGH MUSCLE, THE PROBE ALLEGEDLY STOPPED CYCLING WHILE INSIDE THE PATIENT, AND THE DEVICE ALLEGEDLY WAS UNABLE TO BE REMOVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS TROUBLESHOT WHILE INSIDE THE PATIENT AND BEGAN WORKING AGAIN. THE DEVICE WAS THEN ABLE TO BE REMOVED FROM THE PATIENT AND THE TISSUE SAMPLE WAS OBTAINED FROM THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7912100 ↗
• MalfunctionMay 2, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE VACUUM TUBING ALLEGEDLY DETACHED FROM THE SYRINGE DURING A SAMPLE SEQUENCE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6539006 ↗