Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction problems, and failure to obtain tissue samples.
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 involves a medical device with functional failures (leaks, suction issues, failure to obtain samples) that pose a risk of harm (diagnostic failure), but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes, catalog number 7GV Upright (Vertical) - REF ECP017GV. The product is indicated for use in acquiring tissue for diagnosing breast abnormalities. The recall involves 12,833 units distributed worldwide, including the United States, Puerto Rico, and numerous foreign countries.
The recall was initiated due to an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. The affected lot numbers are VTCV0414, VTCW0469, VTCW0470, VTCY0566, VTCZ0640, VTCZ0648, and VTCZ0649.
Healthcare providers and facilities should stop using the affected devices and contact Bard Peripheral Vascular Inc for instructions on returning the product. Patients who have had procedures using these probes should consult their healthcare provider if they have concerns about the results of their biopsy.
The recalled product
- Product
- EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Biopsy Probes
- Affected units
- 12,833
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 (7)
- Lot numbers VTCV0414
- VTCW0469
- VTCW0470
- VTCY0566
- VTCZ0640
- VTCZ0648
- and VTCZ0649.
Distribution
Part of a larger recall action
This product is one of 6 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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