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U.S. Department of Health and Human Services

Class 2 Device Recall EnCor EnCompass Breast Biopsy and Tissue Removal System Console

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 Class 2 Device Recall EnCor EnCompass Breast Biopsy and Tissue Removal System Consolesee related information
Date Initiated by FirmAugust 20, 2026
Date PostedSeptember 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3275-2026
Recall Event ID 99590
510(K)NumberK252681 
Product Classification Instrument, biopsy - Product Code KNW
ProductEnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
Code Information 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
FEI Number 2020394
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
850 W Rio Salado Pkwy
Tempe AZ 85281-3802
For Additional Information Contact
844-823-5433
Manufacturer 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 Determined
Cause 2		Software design
ActionOn 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 BDRC33@bd.com 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: productcomplaints@bd.com, or phone: 1-844-823-5433
Quantity in Commerce99
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KNW
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