ENCOR® ECP0110GVRecalls & reported problems

Summary

The FDA's MAUDE database contains 392 adverse event reports that list this exact device (DI 00801741086250), received between Dec 23, 2015 and Aug 26, 2026 — classified as 12 injuries, 380 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (260 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 25 most recent of 392 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT WAS PREPPED FOR A MAMMOGRAPHY BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, USING THE ENCOR BIO PROBE. PRIOR TO THE PROCEDURE, THE BIOPSY PROBE HAD A GOOEY WHITE SUBSTANCE IN THE SAMPLE NOTCH AREA. NO COAXIAL WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23130237 ↗
• 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 23107004 ↗
• 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. HOWEVER, THERE WERE NO REPORTED INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23106795 ↗
• 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 23100123 ↗
• 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 23099543 ↗
• MalfunctionJul 9, 2025Dull, Blunt; Device Contamination with Chemical or Other Material; Dull, Blunt; Device Contamination with Chemical or Other Material

  ON (B)(6) 2024, A PATIENT UNDERWENT FOR A STEREOTACTIC VACUUM BREAST BIOPSY PROCEDURE USING ENCOR BIOPSY PROBE. PRIOR TO THE PROCEDURE, WHEN ATTACHING AND CALIBRATING THE PROBE TO THE ENCOR ENSPIRE HANDLE, THE PROBE MADE A HISSING SOUND THAT SOUNDED LIKE IT¿S NOT AIRTIGHT. IT WAS FURTHER REPORTED THAT DEVICE CONTAMINATION WITH CHEMICAL AND DULL NEEDLE WAS IDENTIFIED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455565 ↗
• MalfunctionJul 9, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2024 A PATIENT UNDERWENT FOR A STEREOTACTIC VACUUM BREAST BIOPSY USING ENCOR BIOPSY PROBE. PRIOR TO THE PROCEDURE, WHEN ATTACHING AND CALIBRATING THE PROBE TO THE ENCOR ENSPIRE HANDLE, THE PROBE MADE A HISSING SOUND THAT SOUNDED LIKE IT¿S NOT AIRTIGHT. IT WAS FURTHER REPORTED THAT DEVICE CONTAMINATION WITH CHEMICAL WAS IDENTIFIED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455562 ↗
• MalfunctionJul 9, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) ,2024 A PATIENT UNDERWENT FOR A STEREOTACTIC VACUUM BREAST BIOPSY PROCEDURE USING ENCOR BIOPSY PROBE. PRIOR TO THE PROCEDURE, WHEN ATTACHING AND CALIBRATING THE PROBE TO THE ENCOR ENSPIRE HANDLE, THE PROBE MADE A HISSING SOUND THAT SOUNDED LIKE IT¿S NOT AIRTIGHT. IT WAS FURTHER REPORTED THAT DEVICE CONTAMINATION WITH CHEMICAL WAS IDENTIFIED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455059 ↗
• InjuryJun 25, 2025Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A STEREOTACTIC GUIDED BREAST BIOPSY AND MARKER PLACEMENT PROCEDURE USING VIA FATTY DENSITY TISSUE THE ENCOR PROBE WITH SENOMARK ULTRACOR MARKER. DURING THE PROCEDURE, A CLIP IS INSERTED AND SUBSEQUENTLY CANNOT BE REMOVED. THE CLIP GUIDE AND THE ENTIRE NEEDLE BECOME STUCK IN THE PATIENT'S BREAST. FURTHER IT WAS REPORTED THAT A LARGER INCISION WAS MADE AT THE NEEDLE ENTRY SITE. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 22326183 ↗
• InjuryMay 26, 2025Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ELECTRON-TRIGGERED X-RAY IMAGING BREAST TISSUE MARKER PLACEMENT PROCEDURE THROUGH GREASE DENSITY TISSUE USING SENOMARK ULTRA AND ENCOR PROBE. DURING THE PROCEDURE, THE MARKER WAS ALLEGEDLY DIFFICULT TO INSERT INTO THE PROBE. IT WAS FURTHER REPORTED THAT THE MARKER FAILED TO DEPLOY. AFTER WASHING AND PLACING THE MARKER ON THE NEEDLE, THE MARKER DID NOT COME OUT OF THE GUIDE, REMAINING HALFWAY OPEN, WHICH MADE IT DIFFICULT TO REMOVE THE NEEDLE FROM THE BREAST. REPORTEDLY NEEDLE WAS REMOVED WITH THE HELP OF AN EMERGENCY SURGEON, BY MAKING A LARGER INCISION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083418 ↗
• MalfunctionMar 18, 2025Nonstandard Device; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Nonstandard Device; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A STEREOTACTIC GUIDED VACUUM ASSISTED BREAST BIOPSY PROCEDURE, CHECKED THE CHAMBER AND FOUND THE METAL THAT MAKES UP THE TIP OF THE PROBE NEEDLE. MAYBE IT FELL BECAUSE OF POOR ADHESION IN THE MANUFACTURING PROCESS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628525 ↗
• InjuryOct 28, 2024Difficult to Remove; Suction Problem; Material Twisted/Bent; Difficult to Remove; Suction Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STEREOTAXIC GUIDED VACUUM ASSISTED BREAST BIOPSY PROCEDURE, THE EQUIPMENT ALLEGEDLY GENERATED AN ERROR ON THE SCREEN AND STOPPED WORKING CAUSING THE NEEDLE TO BECOME STUCK WITHIN THE PATIENT'S BREAST. IT WAS FURTHER REPORTED THAT AS THE NEEDLE WAS BEING REMOVED, TISSUE WAS IDENTIFIED DRAGGING FROM THE NEEDLE WHICH ALLEGEDLY CAUSED THE TISSUE TEAR AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND HAD INCREASED BLEEDING REQUIRING ICE COMPRESSION AND TWO PERCENT LIDOCAINE TO BE ADMINISTERED. THE PATIENT IS REPORTED TO BE STABLE NOW.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ecchymosis; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 20551032 ↗
• MalfunctionSep 14, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A STEREOTACTIC BREAST BIOPSY PROCEDURE, THE PRODUCT PACKAGE WAS ALLEGEDLY MISLABELED AS 10G INSTEAD OF 12G. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20219473 ↗
• MalfunctionJul 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A STEREOTACTIC BREAST BIOPSY PROCEDURE, THE PROBE ALLEGEDLY FOUND CONTAMINATED WITH FOREIGN MATERIAL OVER THE TROUGH AND THE DISTAL PROBE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688818 ↗
• InjuryFeb 20, 2024Material Fragmentation; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST A STEREOTACTIC GUIDED BREAST BIOPSY PROCEDURE, LITTLE METAL SMIDGENS WERE ALLEGEDLY FOUND IN THE PATIENT'S BREAST UNDER STEREO IMAGES. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18738674 ↗
• MalfunctionDec 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PREPARATION OF A STEREO-GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE BASKET OF THE PROBE ALLEGEDLY CAME OFF WHEN TRIED TO LOAD THE DEVICE ONTO THE SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325291 ↗
• MalfunctionDec 7, 2023Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A STEREOTAXIC GUIDED BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, WHEN STARTING THE ASPIRATION, THE EQUIPMENT ALLEGEDLY CRASHED WITH ERROR 1018 INDICATION ON THE SCREEN AND THE SCREEN REMAINED STUCK EVEN ON PRESSING THE RESET BUTTON. IT WAS FURTHER REPORTED THAT WHEN THE NEEDLE WAS REMOVED, THE CUTTING AREA OF THE NEEDLE IN THE METAL AREA WAS ALLEGEDLY FOUND TO BE FRAGMENTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281455 ↗
• InjuryNov 2, 2023Difficult to Remove; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE SAMPLES WERE SUCCESSFULLY COLLECTED AND THEN A CRACKLING NOISE BEGAN AT THE STAGE OF QUADVAC. IT WAS FURTHER REPORTED THAT THE MARKER WAS INSERTED WITH MINIMAL RESISTANCE, BUT THE NEEDLE COULD NOT BE RETRACTED, AND A SURGEON WAS CALLED TO ASSIST THE REMOVAL OF THE NEEDLE. REPORTEDLY, THE SURGEON EVENTUALLY USED A SCALPEL TO DETACH THE BREAST FROM THE NEEDLE AND GENTLY AND VERY SLOWLY RETRACTED THE NEEDLE OUT OF THE BREAST, RESULTING IN THE PATIENT HAVING TO HAVE STICHES. THE HCP WAS UNSURE IF A PART OF THE MARKER WAS LEFT IN SITU (I.E., BROKE OFF AT THE TIP OF THE SHEATH) AND WILL BE RETURNING THE DEVICE FOR EVALUATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18053243 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER COMPLETING A BIOPSY PROCEDURE, THE USER ALLEGEDLY OCCURRED NEEDLE STICK INJURY WHEN PERFORMING TO RECAP THE PROBE TIP WITH PROTECTIVE SLEEVE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17771986 ↗
• MalfunctionJul 6, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Device Contamination with Chemical or Other Material; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A STEREOTACTIC BREAST BIOPSY PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY DIFFICULT TO REMOVE FROM PATIENTS' BREAST. REPORTEDLY, THE PATIENT DEVELOPED HEMATOMA. IT WAS FURTHER REPORTED THAT A FOREIGN SUBSTANCE WAS ALLEGEDLY FOUND AND STUCK TO THE NEEDLE TIP PREVENTING NOTCH OF THE NEEDLE TO CLOSE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17264786 ↗
• MalfunctionMar 3, 2023Image Orientation Incorrect; Difficult to Remove; Image Orientation Incorrect; Difficult to Remove

  IT WAS REPORTED THAT DURING A STEREOTACTIC BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE WAS ALLEGEDLY UNABLE TO BE REMOVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT, THE NEEDLE CAME OUT WITH AN OPEN APERTURE. REPORTEDLY, THE PROBE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477969 ↗