FDA has issued a is notifying U.S. health care professionals of a Class I recall relating to Thoratec’s HeartMate II LVAS pump.
The recall is due to detachment of the bend relief from its intended position around the proximal outflow graft, which may allow the graft to kink or deform, resulting in reduction of blood flow from the pump, pump/graft thrombosis, or perforation of the outflow graft.
Additionally, the metal end of the bend relief may be sharp and cause erosion and cutting of the outflow graft. This product may cause serious adverse health consequences, including death.
Class I recalls are the most serious type of recall, relating to situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death. However in this case it looks like the exercising of a Class I recall is the FDA’s chosen route for getting most attention for a required cautionary change in practice rather than demanding a physical return of the product.
Model numbers affected: 103393, 103695, 104692, 104911, 104912
This isn’t the first time the “bend relief” problem has reared its ugly head. In a European Field Safety Notice issued in February the company drew specific attention to its revised instructions for use, in which it specifically draws attention to the need for full and even connection of the bend relief to the outflow graft in view of reports of disconnection.
What to do now?
Thoratec’s corrective action has taken the form of a change to the device labeling in order to provide instructions on how to verify the bend relief is fully engaged with the sealed outflow graft at the time of implant. There is also a new caution statement regarding the bend relief connection.
Clinicians have been instructed to follow the revised instructions for use that clarify the recommended procedure for securing the bend relief to the outflow graft.
It’s called a recall, but the recall notice does not state that a product return should be undertaken. It appears that physical product is not subject to return to Thoratec as the only changes are to the IFU. For clarification, contact the manufacturer or FDA.
The FDA Recall Notice can be found here.