Biosense Webster Recalls Carto 3 EP Navigation System Due to Image Loss
Biosense Webster is recalling the Carto 3 EP Navigation System because the ultrasound image may disappear during use, requiring a system restart.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where the hazard is a loss of real-time data during a procedure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biosense Webster, Inc. is recalling the Carto 3 EP Navigation System, specifically the CARTOSOUND Module, in the United States and worldwide. The recall involves 1,035 units in the U.S. and affects the system when used with SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters.
The recall is due to a software issue where the cardiac ultrasound image may disappear from the system. This issue requires the system to be restarted, which can occur while a patient is experiencing pericardial effusion. The affected catalog numbers are C3SOUND, 10439236, 10439072, 10439011, and 10438577.
The recall is classified as Class II by the FDA. New precautions have been added to address the issue. Healthcare providers should contact Biosense Webster for further instructions on how to proceed with the recall and any necessary updates.
The recalled product
- Product
- Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
- Manufacturer
- Biosense Webster, Inc.
- Affected units
- 1,035
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 (5)
- Catalog #: C3SOUND
- 10439236
- 10439072
- 10439011
- 10438577
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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