ENCOR® ECP017GVRecalls & reported problems

Summary

The FDA's MAUDE database contains 243 adverse event reports that list this exact device (DI 00801741086298), received between Apr 17, 2019 and Dec 18, 2025 — classified as 1 injury, 242 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (119 reports).

10 other recalls cover devices cleared under the same FDA submission (K051158); they may or may not involve this specific model.

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 243 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Material Fragmentation; Material Fragmentation

  ON (B)(6) 2025, A PATIENT UNDERWENT A VACUUM ASSISTED BREAST BIOPSY PROCEDURE USING THE ENCOR BIOPSY SYSTEM WITH THE ENCOR BIOPSY PROBE CONTAINING A BREAST MARKER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE VACUUM ASSISTED EXCISION WAS PERFORMED AND IT WAS ALLEGEDLY THAT THE MARKER WAS DAMAGED DURING THE PROCEDURE AND SEVERAL SMALL FRAGMENTS WERE LODGED WITHIN THE SURROUNDING BREAST TISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835894 ↗
• InjuryDec 3, 2025Failure to Cycle; Failure to Cycle

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED VACUUM ASSISTED BREAST BIOPSY USING THE ENCOR PROBE. DURING THE PROCEDURE, DURING THE PROCEDURE, THE CUTTING MECHANISM SUDDENLY CEASED ROTATION. THE SURGEON RESTARTED THE DEVICE. INCREASED BLEEDING POINTS WERE OBSERVED AT THE TISSUE RESECTION SITE, TOTALING 20 ML. EPINEPHRINE WAS ADMINISTERED DURING THE OPERATION, AND PRESSURE WAS APPLIED TO STOP BLEEDING AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23701804 ↗
• MalfunctionOct 24, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE USING THE ENCOR BIO PROBE. DURING THE PROCEDURE, THE NEEDLE COULD NOT BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378624 ↗
• MalfunctionJul 31, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2025, A PATIENT GETTING PREPARED FOR AN ULTRASOUND GUIDED VACUUM ASSISTED BREAST BIOPSY WITH THE ENCOR PROBE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE TORN HOLES WERE OBSERVED AT THE BOTTOM OF THE INNER PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673179 ↗
• MalfunctionJul 28, 2025Break; Contamination; Dull, Blunt; Device Contamination with Chemical or Other Material; Break; Contamination; Dull, Blunt; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE ENCOR PROBE. PRIOR TO THE PROCEDURE, UPON OPENING THE NEEDLE PACKAGE, THE DEVICE THERE WAS LIQUID SPILLED ON IT. IT WAS ALSO REPORTED THAT LIQUID WAS ALLEGEDLY FOUND IN THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628625 ↗
• MalfunctionApr 15, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A VACUUM-ASSISTED BREAST BIOPSY PROCEDURE, THE PROBES OUTER PACKAGING WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER PACKAGE WAS DAMAGED. REPORTEDLY, THERE WAS A BREACH IN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21838222 ↗
• MalfunctionApr 15, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A VACUUM-ASSISTED BREAST BIOPSY PROCEDURE, THE PROBES OUTER PACKAGING WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER PACKAGE WAS DAMAGED. REPORTEDLY, THERE WAS A BREACH IN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21838221 ↗
• MalfunctionApr 15, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A VACUUM-ASSISTED BREAST BIOPSY PROCEDURE, THE PROBES OUTER PACKAGING WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER PACKAGE WAS DAMAGED. REPORTEDLY, THERE WAS A BREACH IN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21838215 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A VACUUM ASSISTED BREAST BIOPSY PROCEDURE, THE PURPLE FOREIGN BODY ALLEGEDLY FELL OUT FROM THE PROBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394681 ↗
• MalfunctionNov 29, 2024Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO VACUUM ASSISTED BREAST BIOPSY PROCEDURE, THE TWO BOXES HAVE A MOLDY PUNGENT SMELL. IT WAS FURTHER REPORTED THAT THE INSPECTION OF THE OUTER PACKAGING IS INTACT, OPEN THE PACKAGING HAS TRACES OF MOLD. THE MOLDY SMELL IS VERY STRONG. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809487 ↗
• MalfunctionFeb 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE PATIENT RETURNED TO THE HOSPITAL WITHIN ONE MONTH OF THE CATHETER PLACEMENT FOR MAINTENANCE AND FOUND THAT THE CATHETER PUNCTURE SITE WAS BROKEN ABOUT 2 CM IN THE BODY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712379 ↗
• MalfunctionAug 8, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER STEREOTACTIC PROCEDURE, A FOREIGN BODY WAS ALLEGEDLY FOUND IN SPECIMEN IMAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17478630 ↗
• MalfunctionAug 7, 2023Suction Problem; Unintended Movement; Suction Problem; Unintended Movement

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH FIBROADENOMA TISSUE, THE NEEDLE ALLEGEDLY WOBBLED ABNORMALLY, AND WE HEARD THE OBVIOUS SOUND OF AIR LEAKAGE FROM THE SEPARATION PLACE OF THE PROBE BODY AND THE SAMPLE CHAMBER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468605 ↗
• MalfunctionJul 11, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, A PACKAGING OF THE BASKET WAS ALLEGEDLY TORN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296391 ↗
• MalfunctionFeb 21, 2023Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, THE PACKAGING OF THE BASKET WAS ALLEGEDLY TORN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406781 ↗
• MalfunctionSep 15, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE OUTER PACKAGING OF THE DEVICE ALLEGEDLY FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15425595 ↗
• MalfunctionJul 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH FIBROADENOMA TISSUE, THE OUTER PACKAGING OF THE DEVICE ALLEGEDLY FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15109770 ↗
• MalfunctionApr 8, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PACKAGING OF THE DEVICE ALLEGEDLY FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14049743 ↗
• MalfunctionDec 1, 2021Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Packaging Problem; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE SEAL HAS BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12906228 ↗
• MalfunctionNov 18, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH FIBROADENOMA TISSUE, THE OUTER PACKAGE OF THE PRODUCT WAS ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED BY MINI-INVASIVE SURGICAL OPERATION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833750 ↗
• MalfunctionSep 4, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12426234 ↗
• MalfunctionSep 4, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12426231 ↗
• MalfunctionSep 4, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PROBE PACKAGING WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12426172 ↗
• MalfunctionSep 3, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421614 ↗
• MalfunctionAug 23, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND BREAST BIOPSY THROUGH FIBROADENOMA TISSUE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352364 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051158. One submission often covers many models, so check the product and lot details in each record.

• Z-1434-2020 · Jan 3, 2020 · Terminated
  Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
• Z-1431-2020 · Jan 3, 2020 · Terminated
  Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
• Z-1433-2020 · Jan 3, 2020 · Terminated
  Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
• Z-1432-2020 · Jan 3, 2020 · Terminated
  Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
• Z-2209-2019 · May 2, 2019 · Terminated
  EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in a
• Z-2210-2019 · May 2, 2019 · Terminated
  EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV. Product Usage:
• Z-2214-2019 · May 2, 2019 · Terminated
  EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Ind
• Z-2211-2019 · May 2, 2019 · Terminated
  EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 12G - REF ECP0112G. Product Usage: Indicated for use in a
• Z-2213-2019 · May 2, 2019 · Terminated
  EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage: Indicated for use in acqu
• Z-2212-2019 · May 2, 2019 · Terminated
  EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: