Z-3275-2026

EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model...

Name: Z-3275-2026 EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model...
Creator: Bard Peripheral Vascular Inc
Published: 2026-08-20
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2026-08-20 / Open, Classified

FDA source

Recall record

Recall number: Z-3275-2026
Status: Open, Classified
Initiated: 2026-08-20
Posted: 2026-09-25
Recalling firm: Bard Peripheral Vascular Inc
Product: EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
Product code: KNW Instrument, Biopsy
Reason for recall: 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.
FDA root cause: Software design
Action: On 8/20/2026, correction notices were mailed to customer who were asked to do the following: 1.If calibration cannot be completed, clinicians should first follow the troubleshooting instructions provided on the screen and in the Instructions for Use (IFU). If the issue persists, the probe should be replaced and the process repeated. If unsuccessful, an alternative biopsy driver or system should be used, as clinically appropriate. 2. If a pressure sensor error is observed, clinicians should follow the troubleshooting instructions provided on the screen and in the Instructions for Use (IFU). If the error occurs and the system cannot be returned to normal operations, discontinue use of the affected system and complete or reschedule using alternative equipment, as clinically appropriate. No additional follow-up is recommended for patients whose procedures were completed without complication. 3. If affected devices function as intended or if the error codes can be cleared, facilities can continue to use them prior to software update. 4. Post the correction notice on or near affected devices until the software has been updated. 5. Ensure devices are available for the update. 6. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Share this notification with all product users within your facility network to ensure they are also aware of this product correction. If the affected products have been distributed further, please ensure that these entities are contacted and informed of the correction. 7. Complete and return the response form via email to [email protected] Firm has developed a software solution to address these issues. A firm representative will contact your facility to arrange the update. If you require assistance, contact the firm via email: [email protected], or phone: 1-844-823-5433
Quantity in commerce: 99
Distribution: US Nationwide distribution in the states of KS, SC, CA, TX, GA, NC, PA, SC, ID, MI, KY, CT, IL, VA, MA, WI, NY, IN, TN, OH, UT.
Product codes and lots: Software Versions 1.1.1.10207 and 1.2.0.12133. UDI-DI: 00801741235221 and 00801741234248. Serial Numbers: VTLNPX06, VTLNPX0F, VTLNPX0D, VTLNPX08, VTLNPX0K, VTLNPX0A, VTLNPX0C, VTLNPX0L, VTLNPX0J, VTLNPX04, VTLNPX0H, VTLNPX02, VTLPPX1G, VTLPPX1D, VTLPPX1C, VTLPPX1M, VTLPPX2H, VTLPPX2I, VTLPPX2F, VTLQPX15, VTLQPX1Q, VTLQPX1G, VTLQPX14, VTLQPX0T, VTLQPX1Y, VTLQPX1M, VTLQPX2G, VTLQPX1O, VTLQPX1K, VTLQPX19, VTLQPX2E, VTLQPX1W, VTLQPX10, VTLQPX1Z, VTLQPX24, VTLQPX21, VTLQPX0X, VTLQPX1E, VTLQPX0U, VTLQPX26, VTLQPX2F, VTLQPX25, VTLQPX0Z, VTLQPX18, VTLQPX28, VTLQPX20, VTLQPX27, VTLQPX11, VTLQPX2B, VTLQPX1F, VTLQPX2H, VTLQPX41, VTLQPX3T, VTLQPX43, VTLRPX0R, VTKYPX09, VTKYPX44, VTKYPX46, VTKYPX47, VTKYPX48, VTKYPX49, VTKZPX14, VTKZPX15, VTKZPX20, VTKZPX17, VTLNPX4I, VTLNPX49, VTLNPX4G, VTLNPX4N, VTLNPX4E, VTLNPX4L, VTLNPX44, VTLNPX46, VTLNPX4C, VTLPPX27, VTLPPX28, VTLPPX29, VTLPPX1Z, VTLPPX37, VTLPPX3B, VTLPPX34, VTLPPX38, VTLPPX36, VTLQPX0Q, VTLQPX0B, VTLQPX0E, VTLQPX0P, VTLQPX0F, VTLRPX0X, VTLRPX0Z, VTKYPX07, VTKYPX06, VTKYPX04, VTLNPX4B, VTLNPX42, VTLNPX4F, VTLPPX3D, VTLQPX0M, VTKYPX51

Product code KNW

K252681Class IIEnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. / cleared 2025-12-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-29. View this recall on fda.gov (opens on fda.gov)