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EnCor EnCompass recallZ-3275-2026 · Bard Peripheral Vascular Inc · initiated Aug 20, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Bard Peripheral Vascular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Software design

What the company is doing

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

Recall details

Recall number
Z-3275-2026
Status
Open, Classified
Initiated by the company
Aug 20, 2026
Posted by the FDA
Sep 25, 2026
Recalling firm
Bard Peripheral Vascular Inc
Quantity
99
Product code
KNW
FDA submissions
K252681
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 description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K252681 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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