MONOPTY 211616Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741084720), received between Dec 30, 2020 and Feb 14, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2024Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE GRIP OF THE DEVICE ALLEGEDLY FAILED TO ROTATE WHEN TRIED TO SET THE INNER AND OUTER NEEDLES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704915 ↗
• MalfunctionNov 15, 2022Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL TISSUE, THE DEVICE ALLEGEDLY SELF ACTIVATED. A COAXIAL WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795921 ↗
• MalfunctionNov 15, 2022Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL TISSUE, THE DEVICE ALLEGEDLY SELF ACTIVATED. A COAXIAL WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795794 ↗
• MalfunctionNov 15, 2022Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL TISSUE, THE DEVICE ALLEGEDLY SELF ACTIVATED. A COAXIAL WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795763 ↗
• MalfunctionSep 26, 2022Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY SELF-ACTIVATED AFTER THE SECOND SLIDE WAS PRIMED. A COAXIAL INTRODUCER WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484153 ↗
• MalfunctionDec 30, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE FOREIGN MATERIAL WAS ALLEGEDLY FOUND INSIDE THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094327 ↗