Product Wiki · Recalls · Health Canada — Medical Devices

CARDIOSAVE SYSTEM — recall 54716

Health Canada — Medical Devices · Canada · 2016-01-22 · Type II

As described by Health Canada — Medical Devices: CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP (2015-12-21)

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
54716
Date of alert
2016-01-22
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: In some CARDIOSAVE IABPs, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates. When the scroll compressor fails, one of two high priority alarms will appear on the IABP display and patient therapy could be interrupted.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cardiosave-system-hybrid-rescu

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.