Product Wiki · Recalls · Health Canada — Medical Devices

HeartMate 3 Sealed Outflow Graft with bend relief (2019-03-31) — recall 59331

Health Canada — Medical Devices · Canada · 2019-04-12 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59331
Date of alert
2019-04-12
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: There have been reports globally that the HeartMate 3 Outflow Graft exhibited a disconnected screw ring or did not tighten completely and leaked during preparation or implant. The c-ring within the Outflow Graft assembly may not have properly seated during manufacturing. If it is insufficiently seated, it would render the device nonfunctional and would leak during an implant procedure.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/heartmate-3-sealed-outflow-gra

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