Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real

FDA device recall Z-0002-2016 · posted 2015-10-01 · Terminated

Recall details

Recalling firm

Biosense Webster, Inc.

Reason for recall

Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.

Action taken

A Customer Notification Letter and Acknowledgement Form was distributed to customers on 09/10/15. One letter and form was sent via express mail, addressed to the Risk Management Office and one additional letter and form was sent by the firm's account representative to the Electrophysiology (EP/Cardiology Lab directly at the customer site. The firm's notification letter stated that they want to emphasize the following statement "The intra-cardiac ultrasound image will disappear if the CARTO 3 EP Navigation System power is disrupted and this may present a safety issue if the EP is using the ultrasound to monitor the patien during EP procedure. The ultrasound image will not reappear until the CARTO 3 System is restored." The firm will be updating the product labeling to further reinforce the precautionary statement. The firm requests that customers take the following actions: 1. Read the Field Safety Notification carefully. 2. Pass on this notification to anyone in the facility that needs to be informed of this issue, including appropriate clinical personnel involved in the use of SOUNDSTAR eco Catheters. 3. Review, complete, sign and return the attached Acknowledgement Form in accordance with the instructions on the form. 4. Maintain a copy of this letter with the product. 5. Maintain awareness of the Field Safety Notification For any questions the firm states to contact the BWI sales representative.

Root cause

Device Design

Status

Terminated

Product code

DQK

Quantity affected

1035 (U.S.)

Distribution

Worldwide Distribution. US nationwide, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia,

Date initiated

2015-09-10

Date posted

2015-10-01

Date terminated

2016-05-13

Location

Irwindale, CA

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