Ovation iX Abdominal Stent Graft System Platform (2020-05-07)

Starting date:

May 7, 2020

Posting date:

May 15, 2020

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-73123

Last updated: 2020-05-15

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  Reason
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  Affected products

Affected Products

Ovation iX Abdominal Stent Graft System Platform

Reason

This is a follow-up to the advisory notice of 30 August 2018 and reaffirms treatment recommendations for patients who experience a polymer leak during implantation, provides updated information on the current rate of polymer leaks, the rate of clinical harms and root cause

Affected products