Biosense Webster Guiding Sheath Recalled for Carton Label Mismatch
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheaths are being recalled because the carton label does not match the inner pouch label. No illnesses or injuries have been reported.
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: This is a Class II medical device recall involving labeling discrepancies with no reported illnesses, injuries, or safety incidents. The hazard is documentation-related confusion rather than a defect in the device itself, fitting the rubric category of minor labeling errors.
Plain-English summary
Biosense Webster, Inc. is recalling the Carto Vizigo Bi-Directional Guiding Sheath, 8.5F (Small), model REF D-1385-01-S. A total of 277 units are affected, identified by Lot # 00002137.
The product name, lot number, and product code on the outer carton label do not match the information on the inner label pouch. This labeling discrepancy could create confusion about device identification and lot tracking.
The affected devices were distributed worldwide, including throughout the United States and Japan. Healthcare providers and hospitals that possess this lot should verify product information on both the carton and inner pouch before use and contact Biosense Webster with any questions.
No illnesses or injuries have been reported in connection with this labeling discrepancy.
The recalled product
- Product
- Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
- Manufacturer
- Biosense Webster, Inc.
- Category
- Medical Device — Guiding Sheath
- Hazard
- Affected units
- 277
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 (2)
- Lot # 00002137
- UDI (GTIN) : 10846835016253
Distribution
Part of a larger recall action
This product is one of 2 recalled by Biosense Webster, Inc. 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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