ENCORRecalls & reported problems across all models

We found 17 models of ENCOR by Senorx, Inc. in the FDA's device registry (GUDID). Together they are named in 5,369 adverse event reports in the FDA's MAUDE database, received between Dec 23, 2015 and Sep 22, 2026 — classified as 34 injuries, 5,335 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (4,394 reports).

4 FDA recall records name at least one of these models by its device identifier.

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

ENCOR recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 3, 2020Terminated

   Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.

   Z-1434-2020 · Root cause: Component change control · Recall details · FDA record ↗

2. Jan 3, 2020Terminated

   Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.

   Z-1433-2020 · Root cause: Component change control · Recall details · FDA record ↗

3. Jan 3, 2020Terminated

   Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.

   Z-1432-2020 · Root cause: Component change control · Recall details · FDA record ↗

4. Jan 3, 2020Terminated

   Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.

   Z-1431-2020 · Root cause: Component change control · Recall details · FDA record ↗

Most reported ENCOR problems

ENCOR models

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

• ENCOR® ECP017G

  INSTRUMENT, BIOPSY
  1 recall4,186 reports
• ENCOR® ECP0110GV

  INSTRUMENT, BIOPSY
  392 reports
• ENCOR® ECP0110G

  INSTRUMENT, BIOPSY
  390 reports
• ENCOR® ECP017GV

  INSTRUMENT, BIOPSY
  243 reports
• ENCOR® ECPMR0110G

  INSTRUMENT, BIOPSY
  1 recall9 reports
• ENCOR® ECPMR0110GBT

  INSTRUMENT, BIOPSY
  1 recall1 report
• ENCOR® ECPMR017G

  INSTRUMENT, BIOPSY
  1 recall0 reports
• ENCOR® DRENCOR

  INSTRUMENT, BIOPSY
  48 reports
• ENCOR® ECP0112G

  INSTRUMENT, BIOPSY
  36 reports
• ENCOR® FSENCOR01

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  21 reports
• ENCOR® ENCFINSERT10G

  INSTRUMENT, BIOPSY
  10 reports
• ENCOR® ENCFF02

  INSTRUMENT, BIOPSY
  9 reports
• ENCOR® SCCAN01

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  9 reports
• ENCOR® ECMRINTLOC

  INSTRUMENT, BIOPSY
  7 reports
• ENCOR® DRENCORMR

  INSTRUMENT, BIOPSY
  5 reports
• ENCOR® ECP0112GV

  INSTRUMENT, BIOPSY
  2 reports
• ENCOR® FSENCORMR

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 report

Recent ENCOR adverse event reports

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

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, a patient underwent a vacuum assisted breast biopsy procedure using the EnCor Biopsy System with the EnCor Biopsy Probe. During the procedure, while using the device on a patient, the patients pectoral muscle tissue was injured, resulting in bleeding. The current status of the patient is unknown.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50852710 ↗
• MalfunctionAug 26, 2026Break; Failure to Cycle; Failure to Obtain Sample

  On (b)(6)2026, a patient underwent a vacuum-assisted breast biopsy procedure using an EnCor probe. During the procedure, the needle failed to close correctly after use. It was reported that the device could have cut the tissue; however, the samples obtained were particularly small despite the dense breast tissue. It was further reported that the distal end of the needle was permanently damaged and was noticed at the time of device removal from the patient. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459832 ↗
• InjuryJun 3, 2026Suction Problem; Device-Device Incompatibility

  ON (B)(6) 2026, A PATIENT UNDERWENT A STEREOTACTIC GUIDED VACUUM ASSISTED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE USING THE ENCOR PROBE. DURING THE PROCEDURE, THE PROBE SHOWED A VACUUM ERROR EVEN THOUGH ALL CONSUMABLES WERE TIGHTLY SEALED, AND A CLICKING SOUND WAS HEARD FROM THE ENCOR DRIVER. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA, AND THE BLEEDING COULD NOT BE STOPPED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 25369790 ↗
• InjuryMay 22, 2026Failure to Read Input Signal

  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 25251665 ↗
• InjuryMay 22, 2026Failure to Read Input Signal

  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 25251659 ↗
• MalfunctionMay 13, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE ENCOR ENSPIRE SYSTEM DISPLAYED TWO ERROR CODES, HANDPIECE MEMORY CANNOT READ AND SYSTEM ERROR 0066 WHEN CONNECTED TO THE ENCOR DRIVER. ADDITIONAL INFORMATION INCLUDED IMAGE OF THE DRENCOR SERIAL NUMBER WHICH SHOWS THE LAST DIGIT IS SLIGHTLY SMEARED MAKING IT DIFFICULT TO READ AND NOT CLEARLY LEGIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159455 ↗
• MalfunctionApr 9, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A VACUUM ASSISTED BIOPSY PROCEDURE USING THE ENCOR BIO PROBE. PRIOR TO THE PROCEDURE, FOREIGN OBJECT WAS IDENTIFIED IN PROBE NOTCH PART. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829059 ↗
• MalfunctionMar 17, 2026Leak/Splash; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A MAMMOGRAPHY BREAST BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE ENCORE PROBE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE SEAL BETWEEN THE BACK OF THE PROBE AND THE COLLECTION CHAMBER WAS NOT PROPERLY SECURED. AS A RESULT, THE SEALED UNIT WAS UNABLE TO MAINTAIN THE REQUIRED PRESSURE, WHICH LED TO BLOOD LEAKAGE FROM THE DEVICE. THE LEAKAGE SUBSEQUENTLY CAUSED FAILURE OF A ENCORE DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616414 ↗
• MalfunctionMar 5, 2026Break; Contamination; Crack; Material Discolored; Application Program Problem; Scratched Material

  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 24515939 ↗
• InjuryFeb 13, 2026Leak/Splash

  On (b)(6) 2026, a patient underwent a stereotactic biopsy procedure using Encor Probe device. During the procedure, the patient experienced significant bleeding with blood leakage noted at the needle connection site. The procedure was completed using another device. The current status of the patient was unknown.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24329950 ↗
• InjuryFeb 13, 2026Leak/Splash

  On (b)(6) 2026, a patient underwent a biopsy procedure using Encor Probe device. During the procedure, it was reported that the patient experienced significant bleeding with blood leakage noted at the needle connection site. The procedure was completed using another device. However, the current status of the patient was unknown.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24329944 ↗
• MalfunctionJan 21, 2026Application Program Problem

  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 24141740 ↗
• MalfunctionJan 21, 2026Application Program Problem

  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 24141739 ↗
• MalfunctionJan 5, 2026Unintended Movement

  A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE USING THROUGH THE ENCOR ENSPIRE SYSTEM'S. IT WAS REPORTED THAT DURING A STEREOTACTIC SETUP, THE ENCOR ENSPIRE SYSTEM'S TOUCHSCREEN WAS STICKING ON ONE OF THE SLICES LIKE IT WANTED TO SAMPLE THE SAME AREA TWICE. ADDITIONAL CLARIFICATION WAS RECEIVED STATED THAT THE TOUCHSCREEN WOULDN'T ADVANCE TO THE NEXT SAMPLE LOCATION, EVEN THOUGH MULTIPLE LOCATIONS WERE SELECTED BY THE USER, ONLY THE 12 O'CLOCK POSITION WAS BEING SAMPLED. THE 12 O'CLOCK POSITION WAS SAMPLED TWICE. THE USER KEPT ATTEMPTING TO SELECT THE NEXT SAMPLE LOCATION AND EVENTUALLY WAS ABLE TO COLLECT OTHER TISSUE SAMPLES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954549 ↗
• MalfunctionJan 5, 2026Unintended Movement

  A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE USING THROUGH THE ENCOR ENSPIRE SYSTEM'S. IT WAS REPORTED THAT DURING A STEREOTACTIC SETUP, THE ENCOR ENSPIRE SYSTEM'S TOUCHSCREEN WAS STICKING ON ONE OF THE SLICES LIKE IT WANTED TO SAMPLE THE SAME AREA TWICE. ADDITIONAL CLARIFICATION WAS RECEIVED STATED THAT THE TOUCHSCREEN WOULDN'T ADVANCE TO THE NEXT SAMPLE LOCATION, EVEN THOUGH MULTIPLE LOCATIONS WERE SELECTED BY THE USER, ONLY THE 12 O'CLOCK POSITION WAS BEING SAMPLED. THE 12 O'CLOCK POSITION WAS SAMPLED TWICE. THE USER KEPT ATTEMPTING TO SELECT THE NEXT SAMPLE LOCATION AND EVENTUALLY WAS ABLE TO COLLECT OTHER TISSUE SAMPLES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954547 ↗

Other Senorx, Inc. products

• ENCOR ENSPIRE2 models · 49 reports