Swan-Ganz Thermodilution Catheter Double Lumen (2019-03-31)

Starting date:

March 31, 2019

Posting date:

April 29, 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-69716

Last updated: 2019-04-30

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  Reason
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  Affected products

Affected Products

Swan-Ganz Thermodilution Catheter Double Lumen

Reason

This non-conformance involves a Swan Ganz catheter with incorrect printing on the hub of the catheter in reference to balloon inflation volume.  The catheter has 0.5 mL printed on the catheter hub, but the IFU calls for 0.8 mL to fill the balloon, which is the correct inflation volume.  Under-inflation of the balloon may cause an inability to appropriately float the catheter to wedge position and may make it difficult to obtain a wedge pressure. This may cause device to be removed and re-inserted causing a procedural delay.

Affected products