Product Wiki · Recalls · Health Canada — Medical Devices

Advanta V12 — recall 74409

Health Canada — Medical Devices · Canada · 2023-10-11 · 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: 74409
Date of alert: 2023-10-11
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Cardiovascular
Product type: Medical devices

Reported risk: Atrium/Getinge is initiating a voluntary medical device recall/removal for the Advanta V12 covered stent system due to an identified manufacturing deficiency that may cause a loss of balloon pressure or inability to hold balloon pressure during Advanta V12 balloon-expandable covered stent deployment. Recall start date: September 25, 2023

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advanta-v12-0

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.

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.

Advanta V12 — recall 74409

Related