The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1433-2020·Announced 2020-03-11

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Hazard
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

Distributed in 30 states:

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.

See all 4 products in this recall →

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