Bard EnCor EnCompass Breast Biopsy System Software Recall
Bard Peripheral Vascular Inc is recalling 99 EnCor EnCompass Breast Biopsy and Tissue Removal Systems due to software errors that may interrupt procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device where software errors may lead to procedure interruption or the need for repeat biopsies, fitting the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 99 units of the EnCor EnCompass Breast Biopsy and Tissue Removal System Console and Driver with software. The recall covers specific software versions 1.1.1.10207 and 1.2.0.12133, identified by UDI-DI codes 00801741235221 and 00801741234248, and a list of specific serial numbers. The affected units were distributed nationwide in the United States, including states such as Kansas, South Carolina, California, Texas, Georgia, North Carolina, Pennsylvania, Idaho, Michigan, Kentucky, Connecticut, Illinois, Virginia, Massachusetts, Wisconsin, New York, Indiana, Tennessee, Ohio, and Utah.
The recall is due to potential software errors involving probe calibration and/or handheld driver failure (code HH01-00020009) and pressure sensor issues (code E01-0054000E). These errors may prompt the user to restart and re-calibrate the device. The source text indicates that these errors may lead to the interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or a repeat biopsy.
Healthcare facilities and users should identify affected units by checking the software version, UDI-DI, and serial numbers against the provided list. The source text does not specify a particular consumer action beyond the identification of the defect, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 99
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- VTLNPX0F
- VTLNPX0D
- VTLNPX08
- VTLNPX0K
- VTLNPX0A
- VTLNPX0C
- VTLNPX0L
- VTLNPX0J
- VTLNPX04
- VTLNPX0H
- VTLNPX02
- VTLPPX1G
- VTLPPX1D
- VTLPPX1C
- VTLPPX1M
- VTLPPX2H
- VTLPPX2I
- VTLPPX2F
- VTLQPX15
- VTLQPX1Q
Distribution
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