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 issues, and failure to obtain 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 is classified as FDA Class II and involves a medical device where performance failures (leaks, suction issues) pose a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes, catalog number 12G (REF ECP0112G). The product is indicated for use in acquiring tissue for diagnosing breast abnormalities and is packaged individually in sterile pouches. The recall involves 5,298 units from lot numbers VTCT0275, VTCU0353, and VTCY0543.
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 agency has classified this as a Class II recall.
The affected units were distributed worldwide, including US nationwide distribution (including Puerto Rico) and foreign distribution to numerous countries such as Canada, Australia, China, and the United Kingdom. There was government and foreign distribution, but no military distribution. Healthcare providers and patients should stop using the affected probes and contact the manufacturer for further instructions.
The recalled product
- Product
- EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 12G - REF ECP0112G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Biopsy Probe
- Affected units
- 5,298
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 (3)
- Lot numbers VTCT0275
- VTCU0353
- and VTCY0543.
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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