Heartmate 3 Sealed Outflow Graft With Bend Relief (2019-03-31)

HeartMate 3 Sealed Outflow Graft Recall Abbott is recalling HeartMate 3 Sealed Outflow Grafts with bend relief that were distributed across Canada. The grafts may have a manufacturing defect that could affect their performance. This recall affects patients who have received this device as part of their heart pump system.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-04-12

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/1d1f7237-cad0-497c-8fb2-24ba930a83fa