Boston Scientific Recalls LeVeen Needle Electrode Systems for Incorrect Portuguese Instructions
Boston Scientific is recalling LeVeen Standard Needle Electrode Systems because the Portuguese instructions for use are incorrect. 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation error (incorrect instructions in one language) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Boston Scientific Corporation is recalling 19,716 units of LeVeen Standard Needle Electrode Systems, Sterile. 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.
The recall is due to incorrect Directions for Use (DFU) provided in Portuguese. The source text states that all other languages in the DFU are correct. The affected units were distributed in Brazil, Portugal, and Hong Kong.
Consignees in these regions are being notified. No specific consumer actions are detailed in the source text beyond the notification of consignees.
The recalled product
- Product
- LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of…
- Manufacturer
- Boston Scientific Corporation
- Hazard
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: MOO1262020 with lot number 12328876
- 12334483
- 12476383
- 12647754
- 12820081
- 13226500
- 13794799
- 14056980
- to 14256254 Material Catalog Number: MOO1262030 with lot numbers: 12070030
- 12232431
- 12304529
- 12358495
- 12366221
- 12369009
- 12443954
- 12468608
- 12513817
- 12517660
- 12519936
- 12531020
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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