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

Starting date:

March 31, 2019

Posting date:

April 12, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69546

Last updated: 2019-04-12

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  Reason
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  Affected products

Affected Products

HeartMate 3 Sealed Outflow Graft with bend relief

Reason

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.

Affected products