VACORA® VB14116USRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741079351), received between Sep 11, 2017 and Jun 2, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN BREAST BIOPSY PROCEDURE, THE TUBE ALLEGEDLY DETACHED FROM THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11919243 ↗
• MalfunctionOct 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VB14116US BIOPSY INSTRUMENT ALLEGEDLY DETACHED. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10759398 ↗
• MalfunctionJul 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VB14116US BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED TUBE DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE AGE AND WEIGHT OF THE FEMALE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283226 ↗
• MalfunctionJul 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON VISUAL INSPECTION DURING R&D TESTING OF THE DEVICE, THE DEVICE WAS ALLEGEDLY OBSERVED TO HAVE FOREIGN MATERIAL ON THE NEEDLE TIP WHILE THE TYVEK LID WAS STILL INTACT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7660670 ↗
• MalfunctionMar 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY, WHEN OPENING THE SAMPLE NOTCH AN UNUSUAL SOUND WAS HEARD AND ALLEGEDLY THE TUBING DETACHED FROM SYRINGE. IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED AFTER OBTAINING TWO TISSUE SAMPLES AND THE PROCEDURE WAS COMPLETED WITH THE SAMPLES OBTAINED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7314565 ↗
• MalfunctionOct 25, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE TUBE OF THE PROBE ALLEGEDLY BROKE AND BLOOD SPLATTERED ON THE OPERATOR'S FACE AND HANDS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6976167 ↗
• MalfunctionOct 24, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY, THE TUBE ALLEGEDLY CAME OUT FROM SYRINGE WHILE RETRIEVING THE SECOND SAMPLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6974697 ↗
• MalfunctionOct 10, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE TUBE ALLEGEDLY CAME OUT FROM SYRINGE WHILE RETREIVING THE SECOND SAMPLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6939184 ↗
• MalfunctionSep 11, 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. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856829 ↗