Health product recall

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

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

ExpanSure Transseptal Dilation System

Lot or serial number

ESFA011118
ESFA140319
ESFA201118

Model or catalog number

ESD125-35-67-70-N

Companies
Manufacturer

Baylis Medical Company Inc.

5959 Trans-Canada Highway

Montreal

H4T 1A1

Quebec

CANADA