FINESSE® F14105USRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741085161), received between Mar 30, 2018 and Jan 4, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE DEVICE WAS UNSEALED INSIDE THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106979 ↗
• MalfunctionApr 14, 2020Failure to Cycle; Difficult to Remove; Failure to Cycle; Difficult to Remove

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL F14105US, BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED FAILURE TO CYCLE AND REMOVAL DIFFICULTY. THIS INFORMATION WAS RECIEVED FROM MULTIPLE SOURCES. OF THE TWO MALFUNCTIONS, BOTH INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. ONE PATIENT WAS REPORTED AS FEMALE. WEIGHT AND AGE FOR BOTH PATIENTS WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9959086 ↗
• MalfunctionOct 17, 2019Failure to Cycle; Difficult to Remove; Failure to Cycle; Difficult to Remove

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL F14105US. BIOPSY INSTRUMENT ALLEGEDLY FAILURE TO CYCLE AND DIFFICULT TO REMOVE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL TWO EVENTS HAD NO REPORTED PATIENT INJURY. BOTH PATIENT AGE RANGE FROM 36-55 YEARS OLD, WEIGHT RANGE FROM 125-145 LBS, AND BOTH PATIENTS WERE FEMALE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204206 ↗
• MalfunctionOct 17, 2019Failure to Cycle; Self-Activation or Keying; Failure to Cycle; Self-Activation or Keying

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL F14105US BIOPSY INSTRUMENT ALLEGEDLY FAILED TO CYCLE AND SELF ACTIVATED. THIS MALFUNCTION INVOLVED ONE 63 YEAR OLD FEMALE PATIENT, WEIGHING 220 LBS WITH NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203090 ↗
• MalfunctionJul 22, 2019Failure to Cycle; Difficult to Remove; Separation Failure; Device-Device Incompatibility; Failure to Cycle; Difficult to Remove; Separation Failure; Device-Device Incompatibility

  THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL F14105US BIOPSY INSTRUMENT ALLEGEDLY FAILED TO CYCLE, WAS DIFFICULT TO REMOVE, AND FAILED TO SEPARATE. THERE WAS NO REPORTED PATIENT INJURY. THE FEMALE PATIENTS AGE RANGED FROM 42 YEARS TO 53 YEARS. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813635 ↗
• MalfunctionJul 19, 2019Failure to Cycle; Difficult to Remove; Failure to Cycle; Difficult to Remove

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL F14105US BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED FAILURE TO CYCLE AND DIFFICULT TO REMOVE. THE REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT WAS A 36 YEAR OLD FEMALE, WEIGHING 66 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807973 ↗
• MalfunctionJul 19, 2019Failure to Cycle; Difficult to Remove; Failure to Reset; Failure to Cycle; Difficult to Remove; Failure to Reset

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE EVENTS INDICATED THAT MODEL F14105US BIOPSY INSTRUMENT ALLEGEDLY ALLEGEDLY FAILED TO CYCLE AND WAS ALLEGEDLY DIFFICULT TO REMOVE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE PATIENT WAS A 38 YEAR OLD FEMALE, WEIGHT NOT PROVIDED. THIS EVENT INVOLVED ONE PATIENT WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807664 ↗
• MalfunctionJul 17, 2019Failure to Cycle; Difficult to Remove; Difficult to Advance; Failure to Cycle; Difficult to Remove; Difficult to Advance

  THIS REPORT SUMMARIZES ONE(1) MALFUNCTION. A REVIEW OF THE EVENTS INDICATED THAT DURING A BREAST BIOPSY THROUGH VERY DENSE AND FIBROUS TISSUE, MODEL F14105US BIOPSY INSTRUMENT WAS ALLEGEDLY DIFFICULT TO ADVANCE, FAILED TO CYCLE, AND THEN WAS DIFFICULT TO REMOVE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE.THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE (B)(6) FEMALE PATIENT, WEIGHING 144LBS. THIS PATIENT HAD NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799151 ↗
• MalfunctionOct 4, 2018Difficult to Remove; Failure to Reset; Failure to Disconnect; Difficult to Remove; Failure to Reset; Failure to Disconnect

  IT WAS REPORTED THAT DURING A BREAST BIOPSY IN A HARD DENSITY LESION, AT THE SECOND SAMPLE PASS, THE NEEDLE OF THE DEVICE ALLEGEDLY JAMMED AND WAS UNABLE TO BE REMOVED FROM DRIVER. IT WAS FURTHER REPORTED, THE NEEDLE WAS DIFFICULT TO REMOVE FROM THE TISSUE AND ATTEMPTS TO RESET THE DEVICE ALLEGEDLY FAILED. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7934717 ↗
• MalfunctionMar 30, 2018Failure to Cycle; Difficult to Remove; Failure to Cycle; Difficult to Remove

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, AT THE FOURTH SAMPLE PASS, THE NEEDLE OF THE DEVICE ALLEGEDLY JAMMED AND WAS UNABLE TO BE REMOVED FROM DRIVER. IT WAS FURTHER REPORTED, THE NEEDLE WAS DIFFICULT TO REMOVE FROM THE TISSUE. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7386107 ↗