Today the FDA announced a Class 1 recall — the most serious kind of recall — for a catheter guidance tool called FindrWIRZ Guidewire. Surgeons use the wires to go into blood vessels when placing catheters. But they are defective because a coating on the wires can slough/peel off. According to the Recall notice: “Small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause dangerous blood clots in the patient’s bloodstream and can lead to serious adverse health consequences including embolism, stroke, or death.” Find out more about the recall here. The manufacturer is SentreHeart, a Redwoods, CA firm started in 2005, which recently closed a $35M round of funding to fund a clinical trial on another product.
If you are having a surgery that involves putting guidewires blood vessels, be sure your surgeon knows about this recall before you undergo the procedure. If you have been harmed, click the button above to talk to an advocate.
Picture above taken from recall notice.