Product Wiki · Recalls · Health Canada — Medical Devices

Edwards PASCAL Transcatheter Valve Repair System (2019-06-04) — recall 59290

Health Canada — Medical Devices · Canada · 2019-06-28 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
59290
Date of alert
2019-06-28
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Outside of Canada, Edwards Lifesciences has received limited reports, indicating the potential for a missing component (clasp positioning tool). The clasp positioning tool is attached to the implant system during the packaging operation in manufacturing. There is no affected product in Canada currently in distribution and there is no product retrieval necessary. Consistent with standard practices, all prior customers of this device are instructed to continue their proactive steps to visually inspect all devices prior to use.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/edwards-pascal-transcatheter-v

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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