ENCOR ENSPIRERecalls & reported problems across all models

We found 2 models of ENCOR ENSPIRE by Senorx, Inc. in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Jan 12, 2017 and May 22, 2026 — classified as 2 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ENCOR ENSPIRE problems

ENCOR ENSPIRE models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ENCOR ENSPIRE® E4115

  INSTRUMENT, BIOPSY
  40 reports
• ENCOR ENSPIRE® DS4001

  INSTRUMENT, BIOPSY
  9 reports

Recent ENCOR ENSPIRE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Application Program Problem

  IT WAS REPORTED THAT THE ENCOR FOOT PEDAL VACUUM BUTTON WAS NOT WORKING DURING TWO MAMMOGRAM PROCEDURES. DURING THE FIRST PROCEDURE, THE USER FORGOT THAT THE ENCOR DRIVER ALSO HAD THE VACUUM BUTTON, SO THE USER SKIPPING THE VACUUMING AFTER SAMPLING WHICH CAUSED A 2.3 CM HEMATOMA. DURING THE SECOND PROCEDURE, AFTER THEY SAW ANOTHER HEMATOMA FOR THE SECOND PATIENT, THEN THEY USED THE VACUUM BUTTON ON THE ENCOR DRIVER AND WAS ABLE TO REMOVE THE ADDITIONAL FLUID IN THE BREAST. BECAUSE OF THIS THE SECOND PATIENT HEMATOMA WAS NOT AS SIGNIFICANT. AS THE ENSPIRE SN: (B)(6) WAS USED DURING BOTH PROCEDURES, AND IT IS UNKNOWN WHETHER THE FOOT PEDAL OR THE ENSPIRE CAUSED THE ISSUE. IT WAS IDENTIFIED THAT ENCOR ENSPIRE SN: (B)(6) AND ENCOR FOOT PEDAL SN: (B)(6) WERE BOTH USED TOGETHER AS A SYSTEM DURING BOTH EVENTS LISTED ABOVE. THERE WAS PATIENT INJURY DURING THE TWO EVENTS SINCE BOTH PATIENTS WERE PRESENTED WITH HEMATOMAS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 25251666 ↗
• InjuryMay 22, 2026Application Program Problem

  IT WAS REPORTED THAT THE ENCOR FOOT PEDAL VACUUM BUTTON WAS NOT WORKING DURING TWO MAMMOGRAM PROCEDURES. DURING THE FIRST PROCEDURE, THE USER FORGOT THAT THE ENCOR DRIVER ALSO HAD THE VACUUM BUTTON, SO THE USER SKIPPING THE VACUUMING AFTER SAMPLING WHICH CAUSED A 2.3 CM HEMATOMA. DURING THE SECOND PROCEDURE, AFTER THEY SAW ANOTHER HEMATOMA FOR THE SECOND PATIENT, THEN THEY USED THE VACUUM BUTTON ON THE ENCOR DRIVER AND WAS ABLE TO REMOVE THE ADDITIONAL FLUID IN THE BREAST. BECAUSE OF THIS THE SECOND PATIENT HEMATOMA WAS NOT AS SIGNIFICANT. AS THE ENSPIRE SN (B)(6) WAS USED DURING BOTH PROCEDURES, AND IT IS UNKNOWN WHETHER THE FOOT PEDAL OR THE ENSPIRE CAUSED THE ISSUE. IT WAS IDENTIFIED THAT ENCOR ENSPIRE SN (B)(6) AND ENCOR FOOT PEDAL SN (B)(6) WERE BOTH USED TOGETHER AS A SYSTEM DURING BOTH EVENTS LISTED ABOVE. THERE WAS PATIENT INJURY DURING THE TWO EVENTS SINCE BOTH PATIENTS WERE PRESENTED WITH HEMATOMAS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 25251664 ↗
• MalfunctionMar 5, 2026Application Program Problem

  IT WAS INITIALLY REPORTED THAT THE ENCOR DRIVER FAILED TO INITIALIZE AND STOPPED DETECTING THE PROBE WHILE IT WAS ATTACHED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL DETAILS INDICATE THAT THE ENCOR DRIVER FUNCTIONS INTERMITTENTLY, THEN STOPS SENSING THE NEEDLE AND RETURNS TO THE CALIBRATE SCREEN. WHEN THE USER POWERS ON THE ENCOR ENSPIRE SYSTEM, THE SYSTEM BOOTS UP AND DISPLAYS THE CALIBRATION SCREEN. THE USER ATTACHES THE NEEDLE AND DRIVER TO PERFORM CALIBRATION, AFTER WHICH THE SYSTEM ADVANCES TO THE SAMPLE SCREEN. THE USER PREFERS TO RUN SEVERAL TEST SAMPLES PRIOR TO BRINGING IN A PATIENT TO ENSURE THE NEEDLE IS FUNCTIONING PROPERLY. HOWEVER, DURING THE SAMPLE PATH PROCESS, THE SYSTEM UNEXPECTEDLY RETURNS TO THE CALIBRATION SCREEN. THE NEEDLE DOES NOT MOVE ON THE DRIVER OR LIFT OFF AT ANY POINT. IN SOME INSTANCES, THE DRIVER DOES NOT INITIALIZE UPON STARTUP, PARTICULARLY WHEN CHANGING A PORT. A DIFFERENT NEEDLE HAS BEEN TESTED ON THE ENCOR DRIVER. HOWEVER, ISSUE STILL PERSISTED. THE SALES REP CONFIRMED MULTIPLE NEEDLES WERE USED. SEPARATELY, IT WAS REPORTED THAT PRIOR TO PROCEDURE, THE ENCOR FOOT PEDAL'S BUTTONS WERE UNRESPONSIVE, AND EXPOSED WIRES OBSERVED AT THE BASE. ADDIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516088 ↗
• MalfunctionJan 21, 2026Application Program Problem; Physical Resistance/Sticking

  A 66 YEAR OLD FEMALE PATIENT UNDERWENT A STEREOTACTIC BREAST BIOPSY PROCEDURE USING THE ENCOR ENSPIRE SYSTEM. DURING THE PROCEDURE, ENCOR ENSPIRE SYSTEM UNEXPECTEDLY ENTERED INTO REBOOT MODE WHILE THE NEEDLE WAS INSIDE THE PATIENT'S BREAST. THE PROCEDURE WAS PERFORMED IN AN UPRIGHT POSITION USING VERTICAL APPROACH AT THE CC ANGLE. NO BUTTONS WERE PRESSED ON THE ENCOR FOOT PEDAL OR THE ENCOR DRIVER. WHILE THE NEEDLE WAS IN THE PATIENT'S BREAST AND THE RADIOLOGIST WAS PREPARING TO ADMINISTER ADDITIONAL LIDOCAINE, THE TECHNOLOGIST BELIEVES THE RADIOLOGIST MOVED THE CABLES OUT OF THE WAY BY THE NEEDLE. THEN, THE ENCOR ENSPIRE SYSTEM'S SCREEN SWITCHED TO A REBOOT MODE. SO, THE TECHNOLOGIST POWERED OFF THE ENCOR ENSPIRE SYSTEM AND INSTRUCTED THE RADIOLOGIST TO REMOVE THE LIDOCAINE SYRINGE AND WITHDRAW THE NEEDLE. FURTHERMORE, THE TECHNICIAN HAD POWERED THE ENCOR ENSPIRE SYSTEM BACK ON AND HAD TO REATTACH THE NEEDLE AND RECALIBRATE. THEN, THE TECHNICIAN ATTACHED THE NEEDLE AND THE RADIOLOGIST ADVANCED THE NEEDLE BACK INTO THE PATIENT'S BREAST TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141737 ↗
• MalfunctionDec 17, 2025Break; Application Program Problem; Break; Application Program Problem

  A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE THROUGH ENCOR ENSPIRE SYSTEM, IT WAS REPORTED THAT DURING A STEREOTACTIC VERTICAL APPROACH PROCEDURE WHILE IN "SAMPLE" MODE AND THEY HAVE ALREADY BEGUN TO SAMPLE THE PATIENT TISSUE, THE ENCOR ENSPIRE SYSTEM SUDDENLY REVERTED BACK TO THE "START CALIBRATION" SCREEN. THE USER HAS TO REMOVE THE NEEDLE TO RECALIBRATE AND RE-ENTER THE TISSUE TO COMPLETE THE PROCEDURE. THIS OCCURRED TWICE. IT WAS IDENTIFIED THAT ENCOR ENSPIRE SYSTEM SN (B)(6) ((B)(4)), ENCOR DRIVER SN UNK ((B)(4)) AND ENCOR FOOT PEDAL SN UNK ((B)(4)) WERE USED TOGETHER AS A SYSTEM DURING THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825500 ↗
• MalfunctionDec 17, 2025Break; Application Program Problem; Break; Application Program Problem

  A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE THROUGH ENCOR ENSPIRE SYSTEM, IT WAS REPORTED THAT DURING A STEREOTACTIC VERTICAL APPROACH PROCEDURE WHILE IN "SAMPLE" MODE AND THEY HAVE ALREADY BEGUN TO SAMPLE THE PATIENT TISSUE, THE ENCOR ENSPIRE SYSTEM SUDDENLY REVERTED BACK TO THE "START CALIBRATION" SCREEN. THE USER HAS TO REMOVE THE NEEDLE TO RECALIBRATE AND RE-ENTER THE TISSUE TO COMPLETE THE PROCEDURE. THIS OCCURRED TWICE.IT WAS IDENTIFIED THAT ENCOR ENSPIRE SYSTEM SN: (B)(6), ((B)(4)), ENCOR DRIVER SN: UNK, ((B)(4)) AND ENCOR FOOT PEDAL SN UNK ((B)(4)) WERE USED TOGETHER AS A SYSTEM DURING THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825423 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE ENCOR ENSPIRE CASSETTE. DURING THE PROCEDURE, THE DEVICE ALLEGEDLY HAD A FLUID LEAK. THERE WERE NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377192 ↗
• MalfunctionSep 22, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23106708 ↗
• MalfunctionSep 19, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. HOWEVER, THERE WERE NO REPORTED INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099501 ↗
• MalfunctionSep 19, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. HOWEVER, THERE WERE NO REPORTED INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099480 ↗
• MalfunctionSep 4, 2025Application Program Problem; Application Program Problem

  A PATIENT UNDERWENT A STEREOTACTIC BIOPSY PROCEDURE USING ENCOR ENSPIRE SYSTEM AT VERTICAL APPROACH. DURING THE PROCURE, IT WAS REPORTED THAT THE ENCOR ENSPIRE SYSTEM RETURNED TO THE DRIVER READY SCREEN DURING SAMPLING AFTER CALIBRATION WAS COMPLETED. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS STILL INSIDE THE PATIENT. IMMEDIATELY BEFORE THE SCREEN CHANGED, THE FOOT PEDAL WAS BEING HELD DOWN. REPORTEDLY, THE ENCOR DRIVER HAD SUCCESSFULLY COMPLETED CALIBRATION PRIOR TO THE ISSUE. HOWEVER, THE SCREEN REVERTED TO THE DRIVER READY SCREEN BEFORE PROMPTING THE USER TO RECALIBRATE THE NEEDLE. THE PROCEDURE WAS COMPLETED BY REPLACING THE UNIT WITH ANOTHER ENCOR ENSPIRE SYSTEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22960998 ↗
• MalfunctionJul 15, 2025Missing Information; Missing Information

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCOR ENSPIRE CASSETTE. PRIOR TO THE PROCEDURE, IT WAS NOTICED THAT BOTH THE EXTERNAL AND INTERNAL PACKAGES WERE MISSING THE MANUFACTURING DATE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505404 ↗
• MalfunctionMay 6, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT THE ENCOR DRIVER IS WITHOUT FORCE TO ROTATE THE NEEDLE, PRODUCED AN ERROR DURING THE TIME EXAMINATION. IT WAS FURTHER REPORTED THAT THE ADDITIONAL INFORMATION WAS PROVIDED DURING TWO SEPARATE SAMPLING PROCEDURES. REPORTEDLY, THE ENCOR ENSPIRE SYSTEM EMITTED AN ERROR SOUND AND RETURNED TO THE NEEDLE CALIBRATION SCREEN WITHOUT DISPLAYING AN ERROR MESSAGE. FURTHERMORE, ALL CONSUMABLES WERE EXCHANGED BETWEEN THESE PROCEDURES. IT WAS POSSIBLE TO COMPLETE THE PROCEDURE WITH THE CHANGE OF DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966808 ↗
• MalfunctionMay 6, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT THE ENCOR DRIVER IS WITHOUT FORCE TO ROTATE THE NEEDLE, PRODUCED AN ERROR DURING THE TIME EXAMINATION. IT WAS FURTHER REPORTED THAT THE ADDITIONAL INFORMATION WAS PROVIDED DURING TWO SEPARATE SAMPLING PROCEDURES. REPORTEDLY, THE ENCOR ENSPIRE SYSTEM EMITTED AN ERROR SOUND AND RETURNED TO THE NEEDLE CALIBRATION SCREEN WITHOUT DISPLAYING AN ERROR MESSAGE. FURTHERMORE, ALL CONSUMABLES WERE EXCHANGED BETWEEN THESE PROCEDURES. IT WAS POSSIBLE TO COMPLETE THE PROCEDURE WITH THE CHANGE OF DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966801 ↗
• MalfunctionFeb 19, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DRIVER DID NOT CALIBRATE AND RETURNED TO THE START SCREEN WITHOUT ANY COMMAND. IT WAS FURTHER REPORTED THAT THE PEDAL CALIBRATED SUCCESSFULLY BUT ASKED US TO REMOVE THE DRIVER AFTER COLLECTING THE TWO TO THREE FRAGMENTS, FURTHERMORE, THE DRIVER CALIBRATES CORRECTLY, HOWEVER THE SYSTEM RETURNS TO THE HOME SCREEN WITHOUT ANY COMMANDS. REPORTEDLY, THE COMMUNICATION ISSUE HAS BEEN OCCURRED BETWEEN THE DRIVER OR FOOT PEDAL AND THE SOURCE OF COMMUNICATION FAILURE COULD NOT BE IDENTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407711 ↗

Other Senorx, Inc. products

• ENCOR17 models · 5,369 reports · 4 recalls