Zenith Alpha Abdominal Endovascular Graft (2018-09-17)

Starting date:

September 17, 2018

Posting date:

October 5, 2018

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-67898

• 
  Reason
• 
  Affected products

Affected products

Zenith Alpha Abdominal Endovascular Graft

Reason

This recall is being initiated for one unit of the specified product (Lot number 8344185). The device has been identified as potentially having a fractured stent prior to use. The device has not made patient contact. Due to the potential for the manufacturer having distributed a non-conforming product, William Cook Europe is voluntarily recalling this specific lot number.

Affected products