Medtronic has recalled Kyphon® and Kyphon® Express devices due to the risk of injecting bone cement into a patient’s spinal cord and causing nerve damage, paralysis, pulmonary embolism, cardiac arrest, or death.
Kyphon Bone Filler Recall
In May 2017, Medtronic Inc. sent customers an Urgent Field Safety Notice announcing a recall for all lots of Kyphon® and Kyphon® Express Directional Bone Void Filler devices (Product #F04C) due to a risk of severe injury or death.
The recall was issued after Medtronic received 2 reports of a misalignment issue that could result in injection of bone cement directly into a patient’s spinal cord, bloodstream, or “a direction unintended by the surgeon,” according to Medtronic.
There have been no patient injuries reported to date, but the issue could result in life-threatening adverse events. According to the recall:
“Possible risks associated with this misalignment include cement extravasation into the spinal canal with a possible result of paralysis or nerve injury with a risk of pulmonary embolism or cardiac arrest.”
The problem is that a directional arrow at the proximal end of the recalled devices may not correctly align with the opening on the distal end of the instrument, according to Medtronic.
The recall involves approximately 17,650 units distributed worldwide, according to a Class II recall posted by the U.S. Food and Drug Administration (FDA) on June 3.