Bard Peripheral Vascular Inc — EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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.

Provider

FDA — device enforcement reference

Source observed

8/20/2026, 12:00:00 AM UTC

Source updated

9/25/2026, 12:00:00 AM UTC

Location

Tempe, AZ, US

hazard

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.

notice

Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.

product

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

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.

event number

99590

manufacturer

Bard Peripheral Vascular Inc

recall number

Z-3275-2026

source status

Open, Classified

freshness minutes

180

Source use policy · openFDA reference data; not a real-time public alert service

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