Biosense Webster Recalls CARTO 3 Mapping System Due to Stimulator Hazard
Biosense Webster is recalling 71 CARTO 3 V1.05 systems because a potential hazard may occur when used with Bloom EP Stimulators and other electrophysiology equipment.
What this means for you
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 medical device with a potential hazard that has not yet resulted in reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Biosense Webster, Inc. is recalling 71 units of the CARTO 3 V1.05 Electrophysiology Mapping System (code FG-5400-00). The recall was initiated because the company became aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other electrophysiology (EP) equipment, including the CARTO 3 system.
The affected units were distributed worldwide, including nationwide in the United States and in Belgium, Canada, Denmark, France, Germany, Israel, Italy, the Netherlands, and the United Kingdom. The CARTO 3 system is intended for catheter-based atrial and ventricular mapping and supports electrophysiology procedures.
The source text does not specify the exact nature of the hazard, the number of affected patients, or specific instructions for end-users beyond the initiation of the recall. Healthcare providers and facilities using this equipment should contact Biosense Webster for further guidance on the recall.
The recalled product
- Product
- CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac
- Manufacturer
- Biosense Webster, Inc.
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 (1)
- FG-5400-00
Distribution
Distributed nationwide across the United States.
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