Product Wiki · Recalls · Health Canada — Medical Devices

Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump — recall 63710

Health Canada — Medical Devices · Canada · 2021-12-13 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
63710
Date of alert
2021-12-13
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: The exterior of the cardiosave hybrid and rescue IABP may be susceptible to fluid ingress at specific locations on the device. IABPs contain various electronic circuit boards. Liquid spills, such as saline, can create bridges of resistance between the circuit components; causing the circuit to not function as intended. This can impact initiation or continuation of counterpulsation therapy. Recall start date: Nov 22, 2021
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cardiosave-system-hybrid-rescu

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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.