HeartMate III LVAS Implant Kit (2018-04-05)

Starting date:

April 5, 2018

Posting date:

May 1, 2018

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-66620

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  Reason
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  Affected products

Affected products

HeartMate III LVAS Implant Kit

Reason

Abbott is advising our physician partners that we have received reports of outflow graft twist occlusions in the HeartMate 3 (HM3) Left Ventricular Assist System. As a result, patients whose devices experience these outflow graft occlusions will experience a persistent low flow alarm. Outflow graft twists can result in serious adverse events such as hemodynamic compromise, thrombus, and death.

Affected products