Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1320-2023·Announced 2023-04-12

Biosense Webster guiding sheath recalled for labeling mismatch

Biosense Webster is recalling 316 units of Carto Vizigo guiding sheaths because the carton label does not match the inner sterile pouch label, potentially affecting product identification.

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: This is a minor labeling error on a medical device where the carton label does not match the inner pouch label. No illnesses or injuries have been reported. The mismatch could affect product identification and traceability in clinical settings.

Plain-English summary

Biosense Webster, Inc. is recalling 316 units of Carto Vizigo Bi-Directional Guiding Sheath (8.5F/Medium, REF D-1385-02-S) due to incorrect labeling. The product name, lot number, and product code on the carton label do not match the label information on the inner sterile pouch.

This labeling discrepancy could affect proper product identification and lot traceability in healthcare settings. The recall involves lot 50000224 (UDI/GTIN: 10846835016277).

The affected products were distributed worldwide, including throughout the United States and Japan. Healthcare providers who received this product should verify that the carton and inner pouch labels match before use and contact Biosense Webster, Inc. with any questions or concerns.

The recalled product

Product: Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Manufacturer: Biosense Webster, Inc.
Category: Medical Device
Hazard: labeling-error
identification-mismatch
Affected units: 316

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 # 50000224
UDI (GTIN) : 10846835016277

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

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.

See all 2 products in this recall →

Same manufacturer · Biosense Webster, Inc.

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Same hazard · labeling error