ENCOR® DRENCORMRRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741086083), received between Sep 8, 2022 and Dec 8, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT WHEN TAPPING THE SAMPLE BUTTON ON THE ENCOR MRI DRIVER, INSTEAD OF CLOSING THE SHUTTER IT WILL TAKE A SAMPLE. AFTER COMPLETING A CLOCK FACE, INSTEAD OF STOPPING IT WILL CONTINUE ON AROUND. HAVING THE SCREEN SET TO TAKE ONLY ONE SAMPLE AND HOLDING THE SAMPLE BUTTON ON THE DRIVER TO TAKE ONLY ONE SAMPLE AND THEN LIFTING YOUR FINGER IT WILL CONTINUE TO TAKE A SAMPLE IN THAT POSITION, HAD TO DISCONNECT THE NEEDLE IN ORDER FOR IT TO STOP SAMPLING. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE SAME FACILITY WAS USING THE ENCOR ENSPIRE SYSTEM SN (B)(6) AND ENCOR MRI DRIVER SN (B)(6) IN THE SAME EVENT. THE USER ALSO STATED THIS ISSUE HAS OCCURRED AT A FEW DIFFERENT STEPS - BUT MOSTLY AFTER ADMINISTERING ANESTHETIC OR PLACING THE MARKER. ONCE IT CONTINUED TAKING THE SAMPLES AFTER THE DOCTOR HAS FINISHED THE 'CLOCK FACE' (OBTAINED 6 SAMPLES) AND HAD TAKEN THEIR FINGER OFF THE SAMPLE BUTTON ON THE DRIVER. MODALITY USED WAS MRI. TO STOP THE PROCEDURE ENCOR ENSPIRE SYSTEM WAS TURNED OFF. EVEN THOUGH THE NEEDLE WAS INSIDE THE PATIENT'S BREAST WHEN THIS ISSUE OCCURRED, THERE WAS NO REPORTED PATIENT INJURY, AND NO MEDICAL INTERVENTION WAS NEEDED FOR ANY OF THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751263 ↗
• MalfunctionDec 8, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT WHEN TAPPING THE SAMPLE BUTTON ON THE ENCOR MRI DRIVER, INSTEAD OF CLOSING THE SHUTTER IT WILL TAKE A SAMPLE. AFTER COMPLETING A CLOCK FACE, INSTEAD OF STOPPING IT WILL CONTINUE ON AROUND. HAVING THE SCREEN SET TO TAKE ONLY ONE SAMPLE AND HOLDING THE SAMPLE BUTTON ON THE DRIVER TO TAKE ONLY ONE SAMPLE AND THEN LIFTING YOUR FINGER IT WILL CONTINUE TO TAKE A SAMPLE IN THAT POSITION, HAD TO DISCONNECT THE NEEDLE IN ORDER FOR IT TO STOP SAMPLING. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE SAME FACILITY WAS USING THE ENCOR ENSPIRE SYSTEM SN (B)(6) AND ENCOR MRI DRIVER SN (B)(6) IN THE SAME EVENT. THE USER ALSO STATED THIS ISSUE HAS OCCURRED AT A FEW DIFFERENT STEPS - BUT MOSTLY AFTER ADMINISTERING ANESTHETIC OR PLACING THE MARKER. ONCE IT CONTINUED TAKING THE SAMPLES AFTER THE DOCTOR HAS FINISHED THE 'CLOCK FACE' (OBTAINED 6 SAMPLES) AND HAD TAKEN THEIR FINGER OFF THE SAMPLE BUTTON ON THE DRIVER. MODALITY USED WAS MRI. TO STOP THE PROCEDURE ENCOR ENSPIRE SYSTEM WAS TURNED OFF. EVEN THOUGH THE NEEDLE WAS INSIDE THE PATIENT'S BREAST WHEN THIS ISSUE OCCURRED, THERE WAS NO REPORTED PATIENT INJURY, AND NO MEDICAL INTERVENTION WAS NEEDED FOR ANY OF THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751259 ↗
• MalfunctionDec 8, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT WHEN TAPPING THE SAMPLE BUTTON ON THE ENCOR MRI DRIVER, INSTEAD OF CLOSING THE SHUTTER IT WILL TAKE A SAMPLE. AFTER COMPLETING A CLOCK FACE, INSTEAD OF STOPPING IT WILL CONTINUE ON AROUND. HAVING THE SCREEN SET TO TAKE ONLY ONE SAMPLE AND HOLDING THE SAMPLE BUTTON ON THE DRIVER TO TAKE ONLY ONE SAMPLE AND THEN LIFTING YOUR FINGER IT WILL CONTINUE TO TAKE A SAMPLE IN THAT POSITION, HAD TO DISCONNECT THE NEEDLE IN ORDER FOR IT TO STOP SAMPLING. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE SAME FACILITY WAS USING THE ENCOR ENSPIRE SYSTEM SN (B)(6) AND ENCOR MRI DRIVER SN (B)(6) IN THE SAME EVENT. THE USER ALSO STATED THIS ISSUE HAS OCCURRED AT A FEW DIFFERENT STEPS - BUT MOSTLY AFTER ADMINISTERING ANESTHETIC OR PLACING THE MARKER. ONCE IT CONTINUED TAKING THE SAMPLES AFTER THE DOCTOR HAS FINISHED THE 'CLOCK FACE' (OBTAINED 6 SAMPLES) AND HAD TAKEN THEIR FINGER OFF THE SAMPLE BUTTON ON THE DRIVER. MODALITY USED WAS MRI. TO STOP THE PROCEDURE ENCOR ENSPIRE SYSTEM WAS TURNED OFF. EVEN THOUGH THE NEEDLE WAS INSIDE THE PATIENT'S BREAST WHEN THIS ISSUE OCCURRED, THERE WAS NO REPORTED PATIENT INJURY, AND NO MEDICAL INTERVENTION WAS NEEDED FOR ANY OF THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751253 ↗
• MalfunctionSep 10, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT WHEN TAPPING THE SAMPLE BUTTON ON THE ENCOR MRI DRIVER, INSTEAD OF CLOSING THE SHUTTER IT WILL TAKE A SAMPLE. AFTER COMPLETING A CLOCK FACE, INSTEAD OF STOPPING IT WILL CONTINUE ON AROUND. HAVING THE SCREEN SET TO TAKE ONLY ONE SAMPLE AND HOLDING THE SAMPLE BUTTON ON THE DRIVER TO TAKE ONLY ONE SAMPLE AND THEN LIFTING YOUR FINGER IT WILL CONTINUE TO TAKE A SAMPLE IN THAT POSITION, HAD TO DISCONNECT THE NEEDLE IN ORDER FOR IT TO STOP SAMPLING. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE SAME FACILITY WAS USING THE ENCOR ENSPIRE SYSTEM SN (B)(6) AND ENCOR MRI DRIVER SN (B)(6) IN THE SAME EVENT. THE USER ALSO STATED THIS ISSUE HAS OCCURRED AT A FEW DIFFERENT STEPS - BUT MOSTLY AFTER ADMINISTERING ANESTHETIC OR PLACING THE MARKER. ONCE IT CONTINUED TAKING THE SAMPLES AFTER THE DOCTOR HAS FINISHED THE 'CLOCK FACE' (OBTAINED 6 SAMPLES) AND HAD TAKEN THEIR FINGER OFF THE SAMPLE BUTTON ON THE DRIVER. MODALITY USED WAS MRI. TO STOP THE PROCEDURE ENCOR ENSPIRE SYSTEM WAS TURNED OFF. EVEN THOUGH THE NEEDLE WAS INSIDE THE PATIENT'S BREAST WHEN THIS ISSUE OCCURRED, THERE WAS NO REPORTED PATIENT INJURY, AND NO MEDICAL INTERVENTION WAS NEEDED FOR ANY OF THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012636 ↗
• MalfunctionSep 8, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO STOP SAMPLING AND RESULTED IN TAKING AROUND 5 EXTRA SAMPLES THAT WAS NOT REQUIRED. THE VACUUM BUTTON WAS PRESSED TO FORCE STOP THE SAMPLING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15376457 ↗