Bard Biopsy EnCor Probe Recall for Performance Failures
Bard Peripheral Vascular Inc is recalling specific 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 and involves performance failures (leaks, suction issues) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bard Peripheral Vascular Inc is recalling the Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip (REF number ECPMR0110G). The recall covers 2,050 units of the single-use, sterile device, specifically Lot number VTCW0468. These units were inadvertently not included in the scope of a previous recall.
The recall was initiated due to an increase in probe failures, including leaks, suction issues, and the failure to obtain samples. The affected products were distributed to 31 U.S. states and the District of Columbia, as well as 27 foreign countries. The distribution included government channels but no military distribution.
Healthcare providers and consumers should stop using the affected Bard Biopsy EnCor Probes immediately. Users should check their inventory for the specific reference number ECPMR0110G and Lot number VTCW0468. For further information or to arrange a return, contact Bard Peripheral Vascular Inc.
The recalled product
- Product
- Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Biopsy Probe
- Affected units
- 2,050
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 VTCW0468
- UDI number (01)00801741086304(17)200901(10)VTCW0468.
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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