Bard Biopsy EnCor Probe Recall for Performance Failures
Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes performance failures (leaks, suction issues) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Bard Peripheral Vascular Inc is recalling the Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip (REF number ECPMR0110GBT). The recall covers 1,085 units of Lot number VTCV0370. These products are packaged individually in sterile pouches, with 5 pouches per carton, and are designated for single use and prescription only.
The recall was initiated because these specific lot numbers and products were inadvertently not included in the scope of a previous recall. The original recall was conducted due to an increase in probe failures, specifically leaks, suction issues, and failure to obtain samples.
Distribution of the affected units was made to 31 U.S. states and the District of Columbia, as well as 27 foreign countries including Canada, Australia, and the United Kingdom. Government distribution occurred, but no military distribution was reported. Users should stop using the affected probes and contact the manufacturer for further instructions.
The recalled product
- Product
- Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Biopsy Probe
- Hazard
- Affected units
- 1,085
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 (2)
- Lot number VTCV0370
- UDI number (01)00801741086311(17)200801(10)VTCV0370.
Distribution
Part of a larger recall action
This product is one of 4 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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