Heartmate 3 LVAS Implant Kit (2018-05-29)

Starting date:

May 29, 2018

Posting date:

June 14, 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-67030

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  Reason
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  Affected products

Affected products

Heartmate 3 LVAS Implant Kit

Reason

Abbott is providing additional information to the letter recently issued associated with HeartMate 3 (HM3) outflow graft twist occlusions. On April 5th, 2018 Abbott issued a medical device advisory regarding the heartmate 3 left ventricular assist system and reports of outflow graft twist occlusions with a low incidence rate (0.72%). This current communication provides further clarification on the origin of the outflow graft twist, the persistent low flow alarm, additional recommendations for patient management, and future mitigations that will be implemented.

Affected products