ENCOR® ECP0112GVRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741086274), received between Oct 16, 2025 and Nov 26, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Missing Information; Missing Information

  On (b)(6) 2025, a patient was scheduled to undergo a vacuum-assisted breast biopsy procedure using an EnCor probe instrument. Prior to the procedure, during a stock inspection, it was noted that the device labeling information was missing. The device was not used, and there was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653534 ↗
• MalfunctionOct 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE ENCOR BIO PROBE. PRIOR TO THE PROCEDURE, IT WAS OBSERVED THAT A PIECE OF RUBBER WAS PRESENT IN THE NOTCH, WHICH MADE IT UNUSABLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308455 ↗

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-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-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-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-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-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-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-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