Health product recall

Swan-Ganz Double Lumen Monitoring Catheter

Last updated

Summary

Product
Swan-Ganz Double Lumen Monitoring Catheter
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Swan-Ganz Double Lumen Monitoring Catheter

All lots.

110F5

Issue

The Swan-Ganz catheter model 110F5 contain stainless steel bushings and are inappropriately labeled as MR safe. As per ASTM F2503, "MR safe" items include non-conducting, non-metallic, non-magnetic items. A complaint was reported in United Kingdom, when scanning a patient in MRI, artifacts were noticed around the catheter tip. There was no patient harm. no incident was reported in Canada.

Recall start date: July 4, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Edwards Lifesciences LLC

1 Edwards Way, Irvine, California, United States, 92614

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73956

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