Product Wiki · Recalls · Health Canada — Medical Devices

Heartmate 3 LVAS Implant Kit and Modular Cable With Cap (2019-12-03) — recall 63097

Health Canada — Medical Devices · Canada · 2020-01-24 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
63097
Date of alert
2020-01-24
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Reports received of the HeartMate 3 modular cable being incorrectly inserted into the controller by patients during controller exchange. If the modular cable is incorrectly inserted at 180 degrees from the proper orientation, there is potential for erroneous electrical contact to be made, which may cause a blown fuse, confusion for the patient, and the controller to alarm with " controller fault". In this case, although a physical connection appears to have been made, there is no electrical connection to the power pump.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/heartmate-3-lvas-implant-kit-a

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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