Biosense Webster Recalls Pentaray Catheters for Labeling Clarification
Biosense Webster is recalling Pentaray NAV High-Density Mapping Catheters to clarify contraindication language regarding patients with prosthetic valves.
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 for patients with prosthetic valves, which fits the rubric for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Biosense Webster, Inc. is recalling the Pentaray NAV High-Density Mapping Catheter, including catalog numbers D128201 through D128206. The recall involves 13,912 units that were distributed worldwide, including the United States, Canada, and numerous countries in Asia, Europe, and the Middle East.
The recall was initiated to clarify the contraindication language in the Instructions For Use (IFU) and product labeling. Specifically, the company is updating the labeling to address the use of the catheter in patients with prosthetic valves. This is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should check their inventory and records for the affected catalog numbers and lot codes listed in the official recall notice. Users should consult the updated Instructions For Use and product labeling to ensure the device is not used in patients with prosthetic valves, as clarified by the new contraindication language.
The recalled product
- Product
- Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 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
- 13,912
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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