Product Wiki · Recalls · Health Canada — Medical Devices

Heart Vent Catheter, Atrial and Ventricular (2014-10-17) — recall 52244

Health Canada — Medical Devices · Canada · 2014-10-29 · 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
52244
Date of alert
2014-10-29
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Edwards LifeSciences has identified a potential patient safety risk which may occur during the use of venting catheters. The malleable Stylet which aids during insertion of the vent catheter is coated with a white plastic. The white plastic on the Stylet has the potential to become damaged through interaction with the hard plastic suction adapter on the vent catheter. This can result in the disruption of the white plastic coating on the Stylet. There is an increased chance of generating particulate if the Stylet is withdrawn with sharp bends and/or reinserted into the vent catheter. Reinsertion may lead to an increased potential for particulate to enter the vasculature. No injury has been associated with the use of this device. As a result Edwards is adding warnings to the instructions for use included with the affected device models.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/heart-vent-catheter-atrial-and

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.