Biosense Webster Recalls Pentaray Catheters for Labeling Clarification
Biosense Webster is recalling Pentaray Catheters to clarify contraindication language regarding patients with prosthetic valves in the product labeling.
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 and involves a labeling clarification regarding contraindications, which aligns with the rubric for moderate severity involving labeling errors or precautionary measures without reported injuries.
Plain-English summary
Biosense Webster, Inc. is recalling the Pentaray NAV High-Density Mapping ECO Catheter to clarify the contraindication language in the Instructions For Use (IFU) and product labeling. The recall addresses specific information regarding patients with prosthetic valves.
The affected product is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, specifically for recording or stimulation in the atrial and ventricular regions. The catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
This recall involves 59,672 units distributed worldwide, including the United States and numerous international markets. The action is taken to ensure the labeling accurately reflects the contraindications for use in patients with prosthetic valves.
The recalled product
- Product
- Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart…
- Manufacturer
- Biosense Webster, Inc.
- Hazard
- Affected units
- 59,672
Distribution
Distributed nationwide across the United States.
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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