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.
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, 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighBoston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion
FDA (Devices) · 2014-10-29
- HighBoston Scientific iSLEEVE Expandable Introducer Sets Recalled for Hemostatic Valve Leak
FDA (Devices) · 2024-04-03
- HighBoston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion Risk
FDA (Devices) · 2013-10-23
- ModerateBoston Scientific Recalls Auriga XL 4007 Laser System for Cooling Defect
FDA (Devices) · 2019-05-29
- HighBoston Scientific Recalls Emerge Monorail PTCA Catheters Due to Coating Defect
FDA (Devices) · 2019-12-04
- HighBoston Scientific Recalls One Step Button PEG Kits Due to Adapter Defect
FDA (Devices) · 2015-12-16