ENCOR® ECP0110GRecalls & reported problems

Summary

The FDA's MAUDE database contains 390 adverse event reports that list this exact device (DI 00801741086243), received between Jan 13, 2017 and Jun 3, 2026 — classified as 8 injuries, 382 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (236 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 390 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionSep 23, 2025Failure to Cycle; Difficult to Remove; Suction Problem; Failure to Cycle; Difficult to Remove; Suction Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A STEREOTACTIC GUIDED VACUUM ASSISTED BREAST BIOPSY PROCEDURE USING THE ENCOR PROBE. DURING THE PROCEDURE, THE DEVICE JAMMED WITH THE NEEDLE STILL INSIDE THE PATIENT. ALTHOUGH THE EQUIPMENT APPEARED TO BE PERFORMING THE VACUUM FUNCTION, IT WAS NOT. WHEN THE PEDALS WERE PRESSED, THE EQUIPMENT DID NOT RESPOND, AND THE NEEDLE COULD NOT BE REMOVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE NEEDLE FAILED TO CLOSE DUE TO A VACUUM ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23119922 ↗
• InjurySep 2, 2025Failure to Cycle; Device-Device Incompatibility; Failure to Cycle; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE WITH THE ENCOR PROBE AND MARKER PLACEMENT WITH A SENORMARK ULTRA. DURING THE PROCEDURE, A CLICK SOUND WAS HEARD DURING VACUUMING AND THE PATIENT FELT PAIN. THE DEVICE WAS NOT FULLY CLOSED, AND AN OBSTRUCTION WAS FELT. THE MARKER WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE PROVED WAS NOT FULLY CLOSED AFTER REMOVAL. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING SIGNIFICANT BLEEDING, AND A LARGE HEMATOMA WAS PRESENT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 22935671 ↗
• MalfunctionJul 15, 2025Missing Information; Missing Information

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCOR PROBE. 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 22504543 ↗
• MalfunctionJun 13, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2024, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE ENCOR BIO PROBE. DURING THE PREPARATION OF A PROCEDURE, CUSTOMER RECEIVED THE MATERIAL WITH THE WRONG LABEL SO PROCEDURE CAN'T BE DONE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201186 ↗
• MalfunctionJan 6, 2025Dull, Blunt; Device Contamination with Chemical or Other Material; Dull, Blunt; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A STEREOTACTIC GUIDED VACUUM-ASSISTED BREAST BIOPSY THROUGH NORMAL TISSUE DENSITY, THE DEVICE ALLEGEDLY HAD FUZZ BALL OF SOME SORT OF PLASTIC. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076926 ↗
• MalfunctionDec 1, 2024Break; Improper or Incorrect Procedure or Method; Suction Problem; Failure to Obtain Sample; Break; Improper or Incorrect Procedure or Method; Suction Problem; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREAST BIOPSY THROUGH SOFT DENSITY TISSUE, THE SUCTION POWER OF THE DEVICE ALLEGEDLY HAD INSUFFICIENT VACUUM. IT WAS FURTHER REPORTED THAT THE TISSUE ALLEGEDLY COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER METHOD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20815952 ↗
• MalfunctionJan 16, 2024Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY TURNED OUT TO BE COMPLETELY CROOKED. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519976 ↗
• MalfunctionJul 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, JELLY-LIKE MATERIAL ALLEGEDLY ADHERED NEAR THE OPENING GATE OF THE NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17314942 ↗
• MalfunctionMar 24, 2023Break; Break

  IT WAS REPORTED THAT DURING A STEREOTACTIC GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16608638 ↗
• MalfunctionMar 24, 2023Device-Device Incompatibility; Device Contamination with Chemical or Other Material; Device-Device Incompatibility; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A STEREOTACTIC BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE MARKER WOULD NOT FIT THROUGH THE PROBE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16608156 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE PATIENT ALLEGEDLY EXPERIENCED HEMATOMA AND PAIN. REPORTEDLY LOCAL ANESTHETIC AND VACUUM WERE USED TO REDUCE THE HEMATOMA, AND PAIN KILLERS WERE PROVIDED. THE CURRENT PATIENT STATUS WAS UNKNOWN.

  Patient problems: Hematoma; Pain

  MAUDE report 16377656 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE PATIENT ALLEGEDLY EXPERIENCED HEMATOMA AND PAIN. REPORTEDLY LOCAL ANESTHETIC AND VACUUM WERE USED TO REDUCE THE HEMATOMA, AND PAIN KILLERS WERE PROVIDED. THE CURRENT PATIENT STATUS WAS UNKNOWN.

  Patient problems: Hematoma; Pain

  MAUDE report 16377629 ↗
• MalfunctionFeb 8, 2023Failure to Cycle; Suction Problem; Failure to Cycle; Suction Problem

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD SUCTION ISSUE. IT WAS FURTHER REPORTED THAT DEVICE ALLEGEDLY HAD DIFFICULTIES WITH CLOSING THE NEEDLE APERTURE. REPORTEDLY THE APERTURE WAS OPEN WHICH RESULTED IN THE PATIENT HAVING A HEMATOMA. HEMATOMA WAS TREATED WITH COMPRESSION UNTIL NO MORE BLEEDING WAS OBSERVED AND ALSO APPLIED AN ICE PACK TO THE AREA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325996 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED SEVERE PAIN IN SHOULDER AND SPINE REGION. IT WAS FURTHER REPORTED THAT ANTI- INFLAMMATORY DRUGS WERE GIVEN AND IN ONE OF THEM, OPIOIDS WERE USED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 16251820 ↗
• MalfunctionJul 19, 2022Difficult to Remove; Material Deformation; Material Twisted/Bent; Difficult to Remove; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, NEEDLE ALLEGEDLY BENT INSIDE THE PATIENT'S BREAST. IT WAS FURTHER REPORTED THAT NEEDLE ALLEGEDLY DIFFICULT TO REMOVE FROM THE PATIENT. REPORTEDLY THE PROCEDURE WAS COMPLETED AND THE NEEDLE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15050987 ↗
• MalfunctionJul 5, 2022Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH FATTY DENSITY TISSUE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14913369 ↗
• MalfunctionApr 19, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE FOREIGN MATERIAL WAS PRESENT INSIDE THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139743 ↗
• MalfunctionNov 16, 2021Material Fragmentation; Device Contamination with Chemical or Other Material; Material Fragmentation; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD BLACK VISCOUS SUBSTANCE ON THE NEEDLE TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12825210 ↗
• MalfunctionSep 27, 2021Device Contamination with Chemical or Other Material; Noise, Audible; Device Contamination with Chemical or Other Material; Noise, Audible

  IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY HAD FOREIGN MATERIAL. IT WAS FURTHER REPORTED THAT NO ABNORMAL NOISES FROM THE PROBE WERE HEARD. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532461 ↗
• MalfunctionJul 21, 2021Positioning Failure; Difficult to Remove; Positioning Failure; Difficult to Remove

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY STUCK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201027 ↗
• MalfunctionJul 20, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, A PIECE OF PLASTIC WAS ALLEGEDLY PROTRUDING FROM THE BIOPSY CHAMBER. IT WAS FURTHER REPORTED THAT THE MARKER COULD NOT REMOVE FROM THE BIOPSY PROBE AND IN THE END. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194519 ↗
• MalfunctionJun 8, 2021Self-Activation or Keying; Improper or Incorrect Procedure or Method; Self-Activation or Keying; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE NOT USED THE PROPER WAY DUE LACK OF GOOD CLINICAL PRACTICES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11956197 ↗
• MalfunctionApr 21, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY, THE DEVICE ALLEGEDLY CONTAMINATED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698620 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, THE SAMPLE BOX ALLEGEDLY BROKE WHEN THE USER PLACE THE NEEDLE TO BEGIN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612821 ↗