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.
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. 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 nonresect
- Manufacturer
- Boston Scientific Corporation
- Hazard
- 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.
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