EnCor EnCompassRecalls & reported problems across all models

We found 3 models of EnCor EnCompass by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between May 14, 2026 and May 14, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EnCor EnCompass recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 20, 2026Class IIOpen, Classified

   Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.

   Z-3275-2026 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Most reported EnCor EnCompass problems

EnCor EnCompass models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EnCor EnCompass™ ENCPDriver

  Instrument, biopsy
  1 recall0 reports
• EnCor EnCompass™ ENCPConsole

  Instrument, biopsy
  1 recall0 reports
• EnCor EnCompass™ ENCP10G

  Instrument, biopsy
  3 reports

Recent EnCor EnCompass adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING AN ENCOR ENCOMPASS PROBE. PRIOR TO THE PROCEDURE, THE PLASTIC PIECES FOUND ON NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167905 ↗
• MalfunctionMay 14, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING AN ENCOR ENCOMPASS PROBE. PRIOR TO THE PROCEDURE, THE PLASTIC PIECES FOUND ON NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167746 ↗
• MalfunctionMay 14, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING AN ENCOR ENCOMPASS PROBE. PRIOR TO THE PROCEDURE, THE PLASTIC PIECES FOUND ON NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167739 ↗

Other Bard Peripheral Vascular, Inc. products

• MAX-CORE11 models · 8,845 reports · 1 recall
• DENALI Vena Cava Filter2 models · 1,021 reports
• MAGNUM19 models · 571 reports · 1 recall
• Conquest32 models · 560 reports
• Ultraverse RX56 models · 536 reports
• Fluency Endovascular Stent Graft51 models · 532 reports
• Atlas Gold33 models · 427 reports
• Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports