Recall Z-3275-2026 · KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
| Date | Sep 25, 2026 (initiated Aug 20, 2026) |
| Status | Open, Classified |
| 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 |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System Bard Peripheral Vascular, Inc., Dec 12, 2025 |