ENCOR® ECP0112GRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00801741086267), received between Aug 4, 2017 and May 6, 2024 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (22 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2024Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE DEVICE WAS ALLEGEDLY UNABLE TO COLLECT ANY TISSUE, FLUID OR BLOOD OF ANY SORT IN THE SAMPLE CHAMBER. IT WAS FURTHER REPORTED THAT THE PROBE ALLEGEDLY CAME APART IN THE BREAST AND WAS ABLE TO REMOVE ALL THE BROKEN COMPONENTS FROM THE BREAST. NO GUIDE WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248961 ↗
• MalfunctionJul 21, 2021Filling Problem; Suction Problem; Device Contamination with Chemical or Other Material; Filling Problem; Suction Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A PREPARATION FOR A BREAST BIOPSY, THE DEVICE ALLEGEDLY HAD A SUCTION ISSUE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202292 ↗
• MalfunctionJul 21, 2021Suction Problem; Device Contamination with Chemical or Other Material; Suction Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A PREPARATION FOR A BREAST BIOPSY, THE DEVICE WAS ALLEGEDLY HAD A SUCTION ISSUE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202209 ↗
• MalfunctionJul 21, 2021Filling Problem; Suction Problem; Device Contamination with Chemical or Other Material; Filling Problem; Suction Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A PREPARATION FOR A BREAST BIOPSY, THE DEVICE WAS ALLEGEDLY HAD A SUCTION ISSUE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202207 ↗
• MalfunctionJun 22, 2021Crack; Device Contamination with Chemical or Other Material; Crack; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD A FOREIGN MATERIAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038804 ↗
• MalfunctionJun 22, 2021Crack; Device Contamination with Chemical or Other Material; Crack; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, A MATERIAL PIECE OF LIKE NEEDLE COVER WAS ALLEGEDLY FOUND ON THE TISSUE TRAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038800 ↗
• MalfunctionJun 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, ALLEGEDLY A MATERIAL PIECE OF LIKE NEEDLE COVER WAS FOUND ON THE TISSUE TRAY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038770 ↗
• MalfunctionJun 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD A FOREIGN MATERIAL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038767 ↗
• MalfunctionJun 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD A FOREIGN MATERIAL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038766 ↗
• MalfunctionMay 27, 2021Crack; Device Contamination with Chemical or Other Material; Crack; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD A FOREIGN MATERIAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891759 ↗
• MalfunctionMay 26, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD A FOREIGN MATERIAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884462 ↗
• MalfunctionJan 13, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, FOREIGN MATERIAL WAS ALLEGEDLY FOUND ON THE SAMPLE TRAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11160547 ↗
• MalfunctionDec 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY, THE DEVICE ALLEGEDLY HAD A CONTAMINATION OF A FOREIGN MATERIAL WITHIN THE SAMPLE TRAY UPON RETRIEVING THE SAMPLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964257 ↗
• MalfunctionOct 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRIOR TO A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD A FOREIGN MATERIAL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10754649 ↗
• MalfunctionOct 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRIOR TO A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD A FOREIGN MATERIAL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10754526 ↗
• MalfunctionOct 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND-GUIDED BREAST BIOPSY, THE DEVICE ALLEGEDLY HAD A PLASTIC MATERIAL ON THE END OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10754523 ↗
• MalfunctionJul 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES 25 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ECP0112G BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED FOREIGN MATERIAL PRESENT IN DEVICE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THIS MALFUNCTIONS DID NOT INVOLVE PATIENTS. AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10302947 ↗
• MalfunctionJan 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES 27 MALFUNCTIONS. THE INFORMATION REVIEWED INDICATED THAT MODEL ECP0112G ALLEGEDLY EXPERIENCED FOREIGN MATERIAL PRESENT IN THE DEVICE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL OF THE REPORTED MALFUNCTIONS DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. AGE, WEIGHT, AND GENDER WERE NOT REPORTED FOR ANY OF THE PATIENTS.

  Patient problems: No Patient Involvement

  MAUDE report 9588537 ↗
• MalfunctionDec 3, 2019Suction Problem; Suction Problem

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, ALLEGEDLY AIR WAS HEARD LEAKING FROM THE PROBE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9406164 ↗
• MalfunctionNov 14, 2019Suction Problem; Suction Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A BREAST BIOPSY PROCEDURE, ALLEGEDLY AIR WAS HEARD LEAKING FROM THE SEAL OF THE TUBE COLLECTION CHAMBER. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9321868 ↗
• MalfunctionOct 18, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT A ECP0112G BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL. THIS REPORT WAS RECEIVED FROM ONE SOURCE. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9211565 ↗
• MalfunctionOct 17, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES SEVEN MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ECP0112G. BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. SEVEN EVENTS DID NOT INVOLVE A PATIENT. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENTS.

  Patient problems: No Patient Involvement

  MAUDE report 9202997 ↗
• MalfunctionOct 14, 2019Suction Problem; Failure to Obtain Sample; Suction Problem; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLES AND HAD A SUCTION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187890 ↗
• MalfunctionOct 14, 2019Suction Problem; Failure to Obtain Sample; Suction Problem; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLES AND HAD A SUCTION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187831 ↗
• MalfunctionSep 26, 2019Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126642 ↗

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-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-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-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-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-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-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-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