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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01208-1
Product Name/Description Thermocool Smarttouch SF Bi-Directional Navigation Catheter

Product Number: D134805

Lot Numbers.: 17682911L and 17685902L

ARTG Number: 233355
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 18/09/2017
Responsible Entity Johnson & Johnson Medical Pty Ltd
Reason/Issue The manufacturer Biosense Webster has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for two specific lots of Thermocool brand catheters.

Alert 402 implies a ‘Map: magnetic distortion’ when connected to CARTO 3 System. Magnetic distortion may result in inaccurate catheter tip location information on the CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.

Severe complications (e.g. AV block, vascular injury, cardiac perforation) are highly unlikely but may occur due to the physician selecting higher than required power settings for a given anatomical area.

Whilst there have been no reports of adverse events in Australia, one adverse event of pericardial effusion requiring pericardiocentesis with no further patient consequences was reported internationally, and was deemed to be potentially associated with this issue.
Recall Action Recall
Recall Action Instructions 1. Users should immediately inspect the device(s) in possession to determine if they hold affected product, if so quarantine this product prior to returning it to J&J Medical.
2. Complete and return the supplied acknowledgement form, even if no affected product is present, as directed.
3. Return any affected product within 30 business days, by contacting JJM Customer Service on 1800 252 194.
4. Forward this notice to relevant personnel. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable).
5. Maintain awareness of this notice.

This action was closed on the 25/09/2018.
Contact Information 1800 252 194 - JJM Customer Service