Product Wiki · Recalls · Health Canada — Medical Devices

Swan Ganz Thermodilution Catheter (2018-12-17) — recall 58598

Health Canada — Medical Devices · Canada · 2019-01-23 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
58598
Date of alert
2019-01-23
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: This non-conformance involves Swan Ganz catheters with incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. It is possible for unintended treatment due to inaccurate values if the reversal in waveforms is not noticed.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/swan-ganz-thermodilution-cathe

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