ENCOR® ECP017GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4,186 adverse event reports that list this exact device (DI 00801741086281), received between Nov 16, 2016 and Sep 22, 2026 — classified as 8 injuries, 4,178 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (3,781 reports).

1 FDA recall record name this device's identifier.

9 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.

Recalls naming this device

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

Most reported problems

Recent adverse event reports

The 25 most recent of 4,186 reports, 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 ↗
• 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 ↗
• MalfunctionJan 2, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED VACUUM ASSISTED BREAST BIOPSY PROCEDURE USING THE ENCOR PROBE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBE WAS INSERTED INTO THE PATIENT'S BREAST AT THE TIME THE SMALL WHITE PLASTIC FOREIGN BODY WAS DETECTED INSIDE THE PROBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941376 ↗
• MalfunctionSep 12, 2025Failure to Calibrate; Detachment of Device or Device Component; Failure to Calibrate; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A ULTRASOUND-GUIDED VACUUM-ASSISTED BREAST BIOPSY, THE DEVICE ALLEGEDLY DISPLAYED ERROR CODE 1011. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037210 ↗
• MalfunctionSep 9, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE USING ENCOR PROBE INSTRUMENT. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE PACKAGE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001729 ↗
• InjurySep 3, 2025Failure to Obtain Sample; Failure to Obtain Sample

  ON (B)(6) 2025, A PATIENT UNDERWENT A VACUUM ASSISTED BREAST BIOPSY PROCEDURE USING AN ENCOR PROBE,. DURING THE PROCEDURE NEEDLE WAS TAKEN OUT WITHOUT COLLECTING SAMPLE. ADDITIONALLY, THERE WAS A RESIDUAL HEMATOMA, LARGER THAN EXPECTED WHICH WAS RESOLVED WITH CONSERVATIVE TREATMENT. IN WHICH LEAD TO PROCEDURE TIME TAKING LONGER THAN NORMAL, CAUSING MORE DISCOMFORT TO THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Hematoma

  MAUDE report 22949796 ↗
• MalfunctionAug 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT A VACUUM ASSISTED BREAST BIOPSY PROCEDURE USING ENCORE PROBE INSTRUMENT. DURING THE PROCEDURE THEY FOUND A PIECE OF PLASTIC IN THE PROBE NOTCH. PIECES OF PLASTIC ARE IN THE NOTCH GAP, FURTHER, CONCLUDED AS CONTAMINATION. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22848713 ↗
• MalfunctionJul 9, 2025Nonstandard Device; Device Contaminated During Manufacture or Shipping; Nonstandard Device; Device Contaminated During Manufacture or Shipping

  ON (B)(6) 2025, A PATIENT UNDERWENT VACUUM ASSISTED BREAST BIOPSY PROCEDURE USING THE ENCOR BIOPSY SYSTEM WITH THE ENCOR BIOPSY PROBE. PRIOR TO PORT PLACEMENT PROCEDURE, PACKAGE ALLEGEDLY CONTAINS OILY SUBSTANCE IN THE PROBE NOTCH. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455753 ↗
• MalfunctionJan 16, 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 PRIOR TO A BIOPSY PROCEDURE, THE PROBE CHAMBER ALLEGEDLY HAD FOREIGN SUBSTANCE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167177 ↗
• MalfunctionNov 18, 2024Suction Problem; Failure to Obtain Sample; Detachment of Device or Device Component; Suction Problem; Failure to Obtain Sample; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VACUUM ASSISTED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE CONTINUES TO CUT BUT NO SAMPLE WAS TAKEN FURTHER. IT WAS FURTHER REPORTED THAT ONE BLUE BUTTON WAS ALLEGEDLY DROPPED INTO SAMPLE CHAMBER AND DID NOT MAKE THE NEEDLE WORK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703540 ↗
• MalfunctionNov 12, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A VACUUM-ASSISTED BREAST BIOPSY PROCEDURE, A PLASTIC MATERIAL WAS ALLEGEDLY FOUND ALONG WITH TISSUE IN THE CHAMBER AFTER SAMPLING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20661847 ↗
• MalfunctionNov 12, 2024Failure to Obtain Sample; Detachment of Device or Device Component; Failure to Obtain Sample; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH HARD DENSITY TISSUE, THE DEVICE ALLEGEDLY COULD NOT GET A SAMPLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20661543 ↗
• MalfunctionSep 16, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, A PLASTIC MATERIAL WAS ALLEGEDLY FOUND ALONG WITH TISSUE IN THE CHAMBER AFTER SAMPLING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223179 ↗
• MalfunctionSep 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, A PLASTIC MATERIAL WAS ALLEGEDLY FOUND ALONG WITH TISSUE IN THE CHAMBER AFTER SAMPLING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20210244 ↗
• MalfunctionAug 26, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH FIBROADENOMA DENSITY TISSUE, THE NEEDLE ALLEGEDLY HAD A RUST-LIKE CONTAMINATION INSIDE THE TISSUE ACQUISITION HOLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072749 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE STARTING HANDLE OF THE DEVICE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507688 ↗
• MalfunctionMay 22, 2024Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Packaging Problem; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED PRIOR TO AN ULTRASOUND GUIDED BIOPSY PROCEDURE, THERE WAS A PIECE OF PLASTIC WAS ALLEGEDLY ATTACHED TO THE NEEDLE. IT WAS FURTHER REPORTED THAT THE PROBE COVER WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371877 ↗
• MalfunctionMay 3, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PREPARATION OF AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, A PIECE OF PLASTIC WAS ALLEGEDLY FOUND ATTACHED TO THE SURFACE OF THE NEEDLE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236831 ↗
• MalfunctionMay 2, 2024Device Contamination with Chemical or Other Material; Material Deformation; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION OF AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, A PIECE OF PLASTIC WAS ALLEGEDLY FOUND ATTACHED TO THE SURFACE OF THE NEEDLE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229714 ↗
• MalfunctionApr 30, 2024Detachment 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 BREAST BIOPSY PROCEDURE, A SMALL PIECE OF PLASTIC WAS ALLEGEDLY FOUND IN THE SAMPLE BASKET AFTER COLLECTING THE SAMPLE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211543 ↗
• MalfunctionApr 17, 2024Dull, Blunt; Device Contamination with Chemical or Other Material; Dull, Blunt; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, THE FOREIGN PARTICLE WAS ALLEGEDLY FOUND IN THE TIP OF THE NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19123153 ↗
• MalfunctionMar 12, 2024Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884672 ↗
• MalfunctionMar 12, 2024Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884671 ↗
• MalfunctionFeb 27, 2024Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785791 ↗
• MalfunctionFeb 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT ON JANUARY 24, THE GERIATRIC NURSE FOUND THAT THE PUNCTURE SITE OF THE PICC CATHETER IMPLANTED BY THE PATIENT HAD BEEN LEAKING ALL THE TIME WHEN CHANGING THE FLUID, AND IT WAS FOUND THAT THE CATHETER WAS DAMAGED DURING EXTUBATION, AND IT WAS FOUND THAT THERE WAS NO LEAKAGE AFTER REINSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18717618 ↗

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-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-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-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-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-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:
• 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-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-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