Product Wiki · Recalls · Health Canada — Medical Devices

Ovation iX Abdominal Stent Graft System Platform (2020-05-07) — recall 61273

Health Canada — Medical Devices · Canada · 2020-05-15 · Type II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
61273
Date of alert
2020-05-15
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ovation-ix-abdominal-stent-gra

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.