VAGINAL STENT - INFLATABLE (2015-10-17)

Starting date:

October 17, 2015

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-55656

• Reason
• Affected products

Affected Products

VAGINAL STENT - INFLATABLE

Reason

The EC (European Conformity) certificate of all medical devices from the manufacturer Silimed, who is a subcontractor to coloplast, has been temporarily suspended by their notified body due to particles found at the surface of some breast implants. There is no indication that these issues would pose a threat to the implanted person's safety. The suspension also affects vaginal stents placed on the market by Coloplast. In line with recommendations from the authorities, Coloplast requests that all affected devices, with Silimed as point of origin, should be put in quarantine and that use of these devices should be ceased until further notice.

Affected products