Device recall
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
- Recall number
- Z-3275-2026
- Event id
- 99590
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Bard Peripheral Vascular Inc
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 20, 2026
- Center classification date
- Sep 25, 2026
- Product code
- KNW
- Device type
- Instrument, Biopsy
- Reason
- 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.
- Root cause
- Software design
- Quantity
- 99
- Code info
- 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
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K252681
- Location
- Tempe, AZ, United States