MONOPTY 121410Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741084584), received between Mar 29, 2017 and Aug 13, 2024 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Self-Activation or Keying; Failure to Fire; Material Twisted/Bent; Self-Activation or Keying; Failure to Fire; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ECHO GUIDED BREAST BIOPSY PROCEDURE, THE OUTER TUBE ALLEGEDLY DID NOT FIRE, AND THE SAMPLE CANNOT BE COLLECTED PROPERLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19970030 ↗
• MalfunctionJun 4, 2024Failure to Prime; Self-Activation or Keying; Failure to Obtain Sample; Failure to Prime; Self-Activation or Keying; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE TISSUE ALLEGEDLY COULD NOT BE REMOVED. A COAXIAL WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19456546 ↗
• MalfunctionAug 28, 2023Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY SELF-ACTIVATED. THE PROCEDURE WAS COMPLETED USING ANOTHER NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17629677 ↗
• MalfunctionJul 13, 2023Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO OPENING THE PACKAGE, A RED FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315266 ↗
• MalfunctionJul 5, 2023Self-Activation or Keying; Failure to Fire; Self-Activation or Keying; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY FAILED TO FIRE. NO COAXIAL NEEDLE 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 17258309 ↗
• MalfunctionApr 21, 2023Self-Activation or Keying; Device Misassembled During Manufacturing /Shipping; Self-Activation or Keying; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BIOPSY PROCEDURE, THE DEVICE WAS ALREADY ENGAGED WITHOUT ANY MANUAL ACTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782897 ↗
• MalfunctionSep 28, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501035 ↗
• MalfunctionSep 26, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486668 ↗
• MalfunctionSep 20, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15453729 ↗
• MalfunctionMar 30, 2022Self-Activation or Keying; Failure to Fire; Self-Activation or Keying; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY FAILED TO FIRE. IT WAS FURTHER REPORTED THAT THE BUTTONS WAS FELT STUCK. A COAXIAL NEEDLE 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 13951805 ↗
• MalfunctionSep 16, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY SELF-ACTIVATED WHEN IT WAS ROTATED TWICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478956 ↗
• MalfunctionJul 30, 2021Break; Failure to Fire; Device Contamination with Chemical or Other Material; Noise, Audible; Break; Failure to Fire; Device Contamination with Chemical or Other Material; Noise, Audible

  IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN THE DEVICE. IT WAS FURTHER REPORTED THAT AN ABNORMAL SOUND WAS HEARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253214 ↗
• MalfunctionJul 6, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FIRED AUTOMATICALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119476 ↗
• MalfunctionJan 25, 2021Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY FAILED TO PRIME. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11221986 ↗
• MalfunctionNov 3, 2020Material Discolored; Device Contamination with Chemical or Other Material; Material Discolored; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD FOREIGN MATERIAL. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10777049 ↗
• MalfunctionOct 28, 2020Self-Activation or Keying; Self-Activation or Keying

  THIS REPORT SUMMARIZES TWO MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 121410 MONOPTY ALLEGEDLY EXPERIENCED SELF ACTIVATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THIS MALFUNCTION DOES NOT INVOLVED TWO PATIENTS. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10750241 ↗
• MalfunctionApr 10, 2020Difficult to Remove; Difficult to Remove

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 121410 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED DIFFICULT TO REMOVE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE FEMALE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE AGE AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9947946 ↗
• MalfunctionApr 9, 2020Difficult to Remove; Failure to Obtain Sample; Difficult to Remove; Failure to Obtain Sample

  THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 121410 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED FAILURE TO OBTAIN SAMPLE AND DIFFICULT TO REMOVE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. EACH MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9944293 ↗
• MalfunctionOct 25, 2019Self-Activation or Keying; Self-Activation or Keying

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE INFORMATION INDICATED THAT MODEL 121410 BIOPSY INSTRUMENT ALLEGEDLY SELF-ACTIVATED. THIS INFORMATION CAME FROM ONE SOURCE. NO PATIENT WAS INVOLVED AND NO PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9239890 ↗
• MalfunctionOct 16, 2019Self-Activation or Keying; Self-Activation or Keying

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 121410 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED SELF-ACTIVATION OR KEYING. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION DID NOT HAVE ANY PATIENT INVOLVEMENT. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9199791 ↗
• MalfunctionJul 22, 2019Self-Activation or Keying; Self-Activation or Keying

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 121410 BIOPSY INSTRUMENT ALLEGEDLY SELF-ACTIVATED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT DID NOT INVOLVE A PATIENT AND THEREFORE HAD NO PATIENT CONSEQUENCE. THE PATIENT IS FEMALE, BUT WEIGHT AND AGE WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8812359 ↗
• MalfunctionMar 28, 2018Failure to Prime; Detachment of Device or Device Component; Failure to Prime; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STEREOTACTIC GUIDED BREAST BIOPSY, AFTER SIX SAMPLE PASSES, THE DEVICE ALLEGEDLY WAS UNABLE TO PRIME AT FIRST. HOWEVER, ONCE DEVICE WAS PRIMED AND FIRED, THE INNER STYLET DETACHED FROM THE OUTER CANNULA. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7378052 ↗
• MalfunctionMar 9, 2018Failure to Prime; Self-Activation or Keying; Failure to Fire; Failure to Prime; Self-Activation or Keying; Failure to Fire

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ULTRASOUND GUIDED BREAST BIOPSY, THE DEVICE WAS ALLEGEDLY DIFFICULT TO PRIME AND FAILED TO FIRE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS PERFORMED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7328855 ↗
• MalfunctionJan 10, 2018Difficult to Remove; Failure to Obtain Sample; Difficult to Remove; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY IN NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY WAS UNABLE TO OBTAIN TISSUE SAMPLES, AND IN ORDER TO REMOVE THE DEVICE FROM THE BREAST, THE CANNULA HAD TO BE RETRACTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND NO COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7181257 ↗
• MalfunctionJan 10, 2018Difficult to Remove; Self-Activation or Keying; Failure to Obtain Sample; Difficult to Remove; Self-Activation or Keying; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY IN NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY WAS UNABLE TO OBTAIN TISSUE SAMPLES, AND IN ORDER TO REMOVE THE DEVICE FROM THE BREAST, THE CANNULA HAD TO BE RETRACTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND NO COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7181148 ↗