Medtronic Inc. has issued a recall for some of its Kyphon instruments that deliver bone cement after discovering a misalignment issue with the devices that could lead to adverse health consequences and even death.
What’s the Problem?
July 10, 2017 – The directional arrow at the proximal end of recalled KYPHON Directional Bone Void Fillers (product #F04C) may not correctly align with the opening on the distal end of the instrument, according to an urgent field safety notice from the company’s regulatory affairs manager of the United Kingdom and Ireland.
Misalignment of the KYPHON Directional Bone Void Filler may result in the cement being inadvertently injected into the spinal canal. When this occurs, potential health risks may include paralysis or nerve injury with a risk of pulmonary embolism or cardiac arrest.
Medtronic has received 2 reports of misalignment thus far; however, no associated patient injuries have occurred, according to the safety notice.
The recall is ranked as Class II, affecting 17,650 units distributed worldwide.