PRECISE PRO RX NITINOL STENT SYSTEM (2016-05-06)

Starting date:

May 6, 2016

Posting date:

May 24, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-58508

• Reason
• Affected products

Affected products 

1. PRECISE PRO RX NITINOL STENT SYSTEM - 20MM
2. PRECISE PRO RX NITINOL STENT SYSTEM - 30MM
3. PRECISE PRO RX NITINOL STENT SYSTEM - 40MM

Reason

Based on recent complaints and subsequent investigation, Cordis has determined that products made between April 27, 2015 and November 22, 2015 have been associated with an increased frequency of incidents of deployment difficulty and in some instances outer member shaft separation resulting in inability to deploy the stent or partial stent deployment. Product manufactured after November 22, 2015, including product currently manufactured and supplied are not affected. There have been no patient injuries reported to us related to this issue. However, considering the products risk analysis the potential impact of inability to deploy the stent or partial stent deployment include an intra-procedural delay while a replacement device is prepared, vessel damage requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment, or in most severe cases, transient ischemic attack or stroke.

Affected products