Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0080-2013·Announced 2012-10-24

Boston Scientific Recalls Leveen Needle Electrodes Due to Incorrect Portuguese Instructions

Boston Scientific is recalling Leveen Coaccess Needle Electrodes because the Portuguese instructions for use contain errors. The recall affects units distributed in Brazil, Portugal, and Hong Kong.

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. The hazard is a labeling error (incorrect instructions in one language) without reported injuries or deaths, fitting the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.

Plain-English summary

Boston Scientific Corporation is recalling the Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15) because the Directions for Use (DFU) provided in Portuguese are incorrect. The source text notes that all other languages in the DFU are correct. These are disposable, monopolar, electrosurgical devices intended for use with a BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including liver lesions.

A total of 19,716 units were distributed in Brazil, Portugal, and Hong Kong. The recall is limited to the documentation error in the Portuguese language instructions. Consignees in these regions are being notified of the issue.

The recalled product

Product: Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of…
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Electrosurgical Device
Hazard: mis-labeling
Affected units: 19,716

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 (20)

Material Catalog Number: MOO1262230 with lot numbers: 12293473
12580337
12639146
12639181
12642715
12647752
12651931
12653869
12656587
12663028
12663626
12667129
12667787
12741165
12760565
12799352
12825090
12849385
12860811
12895401

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Boston Scientific Corporation 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 3 products in this recall →

Same manufacturer · Boston Scientific Corporation

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Same hazard · mis labeling