Swan Ganz Thermodilution Catheter (2018-12-17)

Starting date:

December 17, 2018

Posting date:

January 23, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68830

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  Reason
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  Affected products

Affected products

Swan Ganz Thermodilution Catheter

Reason

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.

Affected products