ENCOR® ENCFF02Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741086458), received between Oct 5, 2016 and Dec 18, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 18, 2024Device Difficult to Setup or Prepare; Unintended Movement; Device Difficult to Setup or Prepare; Unintended Movement

  IT WAS REPORTED THAT DURING A STEREOTACTIC BIOPSY TARGET WAS SELECTED AND THE NEEDLE WAS ADVANCED INTO THE BREAST AND PRE-FIRE LOCATION AND IMAGES WERE ACQUIRED. THE DOCTOR THEN FIRED THE NEEDLE TO THE TARGET LOCATION BY 2CM. ON FIRING, THE BIOPSY NEEDLE DETACHED FROM THE HANDPIECE. THE NEEDLE WAS NO LONGER ATTACHED TO ITS GUIDE AND THE XY AND Z POSITIONS COULD NO LONGER BE VERIFIED. ON VISUAL INSPECTION, THE NEEDLE WAS IN THE ANTERIOR BREAST AND AWAY FROM CHEST WALL/ANY CRITICAL STRUCTURES. PATIENT WAS DOING FINE. THE NEEDLE WAS SLOWLY RETRACTED, ATTACHED BACK TO THE HOLDER. REPEAT IMAGING WAS PERFORMED, AND A NEW XYZ COORDINATE WERE OBTAINED. THE NEEDLE WAS THEN MANUALLY ADVANCED WITHOUT UTILIZING THE FIRING MECHANISM BY USER. THE NEEDLE WAS DOCUMENTED TO BE AT THE CORRECT XYZ POSITION MANUAL AND THE BIOPSY WAS SUCCESSFULLY PERFORMED. ADDITIONAL CLARIFICATION WAS PROVIDED THAT THE DRIVER DETACHED FROM FIRE FORWARD WHICH CAUSED THE UNINTENDED MOVEMENT OF THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20961120 ↗
• MalfunctionDec 1, 2023Self-Activation or Keying; Component Missing; Firing Problem; Self-Activation or Keying; Component Missing; Firing Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE FIRE FORWARD ALLEGEDLY ONLY SHOOTS FROM ONE SIDE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY FIRES WITHOUT DEPRESSING SAFETY AND TRIGGER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247913 ↗
• MalfunctionSep 15, 2023Contamination; Device Difficult to Setup or Prepare; Failure to Prime; Self-Activation or Keying; Contamination; Device Difficult to Setup or Prepare; Failure to Prime; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE LEVER TO PRIME THE DEVICE ALLEGEDLY CANNOT MOVE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17753890 ↗
• MalfunctionJan 24, 2023Contamination; Unintended Movement; Contamination; Unintended Movement

  IT WAS REPORTED THAT DURING BIOPSY PROCEDURE, THE THREADS ON THE FIRE FORWARD ARE STRIPPED AND IT WILL NO LONGER SCREW ONTO THE HOLOGIC AFFIRM STEREOTACTIC SYSTEM. THIS ISSUE HAS RESULTED IN FAILED VACUUM BIOPSY ON A PATIENT A FEW WEEKS EARLIER WHERE THE DEVICE FELL OFF THE AFFIRM MACHINE DURING THE FIRING OF THE VACUUM NEEDLE, AND HAD TO FORFEIT THE PROCEDURE DUE TO DANGER TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16231799 ↗
• MalfunctionNov 24, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY UNSTABLE WHEN ATTACHED TO THE DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859724 ↗
• MalfunctionAug 19, 2022Contamination; Unintended Movement; Firing Problem; Contamination; Unintended Movement; Firing Problem

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE THROUGH SCATTERED DENSITY TISSUE, THE DEVICE ALLEGEDLY MISFIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15256596 ↗
• MalfunctionAug 20, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING THE BIOPSY PROCEDURE THE DEVICE WAS ALLEGEDLY TAKING SAMPLES APPROXIMATELY 1/2 CENTIMETER ABOVE THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10429654 ↗
• MalfunctionFeb 14, 2017Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING PREPARATION FOR A STEREOTACTIC BREAST BIOPSY, THE FIRE FORWARD ALLEGEDLY FIRED WITHOUT SELECTING THE TRIGGER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6330772 ↗
• MalfunctionOct 5, 2016Bent; Self-Activation or Keying; Bent; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO USE ON PATIENT, THE DEVICE WAS FIRING FORWARD WITHOUT THE HEALTHCARE PROVIDER PRESSING THE FIRE BUTTON. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6000202 ↗