Improper Instructions Cause Heartmate II Pump To Be Recalled

Posted on April 4, 2012

Another recall to share with you this afternoon, this one involving an item that is critical to ensuring lives are preserved.

The Food and Drug Administration has announced a Class I recall of a product known as the Heartmate II, made by Thoratec Corp.  A Class I recall is the most serious form of recalls that there is, and is typically issued on items that might pose an immediate threat.

The Heartmate II is a heart pump that needs to be placed in a patient through surgery.  The problem has to do with the instructions that surgeons are required to follow when installing the pump.  Apparently, an important step was missing from instructions, and an improper procedure resulting from these missed instructions could lead to severe side effects or death.

A new label will contain an updated caution statement.  Revised instructions have been released, and these instructions make clearer how a surgeon is to secure the bend relief component to what’s known as the outflow graft.  Failure to properly secure these two parts can result in the aforementioned severe consequences.

Interestingly, Thoratec is not required to stop marketing the product.

As a personal injury lawyer in San Francisco, I’m sorry to see a product meant to save lives potentially do the opposite.  If someone did have their pump installed incorrectly, then as a Riverside personal injury attorney I sincerely hope that he or she can get the item fixed as quickly as possible.

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