Boston Scientific Recalls Leveen Coaccess Introducer Sets for Incorrect Portuguese Instructions
Boston Scientific is recalling 19,716 Leveen Coaccess Introducer Sets because the Portuguese instructions for use contain errors. The devices were 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, but the hazard is limited to incorrect labeling in a specific language (Portuguese) with no reported injuries or illnesses, fitting the 'Minor labeling errors' criterion.
Plain-English summary
Boston Scientific Corporation is recalling the Leveen Coaccess Introducer Set, a disposable, monopolar electrosurgical device intended for use with a BSC radiofrequency generator. These devices are used for the thermal coagulation necrosis of soft tissues, including the ablation of nonresectable liver lesions. A total of 19,716 units were distributed.
The recall is due to incorrect information in the Directions for Use (DFU) provided in Portuguese. The source text confirms that the DFU in all other languages is correct. The affected units were distributed in Brazil, Portugal, and Hong Kong.
Consignees in the affected regions are being notified of the recall. No specific instructions for end-users are provided in the source text beyond the notification of consignees.
The recalled product
- Product
- Leveen Coaccess Introducer Set. 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 nonresectable liver lesions.
- 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: MOO1262250 with lot numbers: 12303537
- 12304530
- 12318677
- 12376281
- 12516197
- 12526599
- 12564932
- 12863427
- 12868931
- 12900282
- 13020097
- 13075108
- 13093464
- 13131129
- 13364410
- 13487647
- 13488797
- 13489157
- 13563682
- 13600249
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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