Product Wiki · Recalls · Health Canada — Medical Devices

Thermocool Smarttouch Catheters (2013-09-04) — recall 50409

Health Canada — Medical Devices · Canada · 2013-09-19 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
50409
Date of alert
2013-09-19
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Biosense Webster has identified a defect in the production process of the Thermocool SmartTouch catheter which can lead to occlusion of the irrigation lumen. An irrigation fluid flow interruption has the potential to lead to overheating of the ablation tip and formation of char or thrombus, which in turn could pose a thromboembolic risk to the patient. All lots are being removed from the field.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/thermocool-smarttouch-catheter

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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