Optease Retrievable Vena Cava Filter (2013-10-07)

Starting date:

October 7, 2013

Posting date:

October 31, 2013

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-36499

• Reason
• Affected products

Recalled Products

Optease Retrievable Vena Cava Filter 

Reason

Cordis has identified a printing error on one unit of Optease Vena Cava filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring an additional percutaneous procedure to retrieve the filter. All unexpired distributed lots of the Cordis Optease Vena Cava filter are being removed, since it cannot be absolutely determined that no other similar printing errors occurred. This recall is separate from the correction letter of April 3, 2013 (Recall number 83564).

Affected products