CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is recall
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…
Why was CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is recalled?
The recall was initiated because Biosense Webster has become 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 Electropysiology Mapping System.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
FG-5400-00
- 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…
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 71 units total (30 units in US)
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, and United Kingdom.
- Recall date
- September 19, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)