Product Wiki · Recalls · Health Canada — Medical Devices

Edwards Intuity Elite Heart Valve Kit — recall 44433

Health Canada — Medical Devices · Canada · 2017-03-10 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
44433
Date of alert
2017-03-10
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Cutomer notification in response to a potential mislabeling in which a special access programme (SAP) label may be present on the product. The Intuity Elite is commercially approved for sale by Health Canada under licence # 97810. Customers may disregard the SAP sticker as it is no longer in effect.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/edwards-intuity-elite-heart-va

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.

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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.