Medtronic Inc. has recalled all lots of Kyphon® bone cement devices because a misalignment issue could result in nerve damage, paralysis, pulmonary embolism, cardiac arrest, or death.
Kyphon Directional Bone Filler Recall
Medtronic Inc. announced a recall for all lots of the Kyphon® and Kyphon® Express Directional Bone Void Filler devices with an Urgent Field Safety Notice to customers on May 17, 2017,
There were two reports of a misalignment issue that could result in bone cement being injected into a patient’s bloodstream, spinal cord, or “a direction unintended by the surgeon,” according to Medtronic.
No injuries have been reported to date, but the problem could result in life-threatening health consequences for a patient:
“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 instrument may not correctly align with the cutout opening on the distal end of the instrument. The FDA designated it as a Class II recall on June 3, 2017.
The recall involves approximately 17,650 units with Product #F04C, including all lots of the devices. Medtronic is asking customers to identify the recalled devices and remove them from normal storage locations. Medtronic sales representatives will arrange for a return.
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