ExpanSure Transseptal Dilation System (2019-05-12)

Starting date:

May 12, 2019

Posting date:

May 22, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70005

Last updated: 2019-05-22

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  Reason
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  Affected products

Affected Products

ExpanSure Transseptal Dilation System

Reason

Baylis Medical Company, Inc. is voluntarily recalling 3 lots of ExpanSure Transseptal Dilation System due to the potential for presence of particles in the lumen of the ExpanSure Transseptal Dilator. To date, there have been no reports of adverse events associated with this issue. This action has been undertaken as a cautionary measure to avoid the remote possibility of any particles being released into the patient during use of the device.

Affected products