Recalled Medtronic Guidewires Get FDA's Highest-Risk Classification

By Sara Jerome,
@sarmje

The FDA has sounded the alarm bell about the safety of certain Medtronic guidewires. 

"Regulators have determined that defects in some medical devices made by Medtronic have the potential to cause serious harm or death, according to statements issued by the company and FDA," the Wall Street Journal reported.  

Last month, Medtronic recalled nearly 15,000 guidewire products from hospitals and distributors around the world because some models "from recent lots have the potential for the coating on their surface to delaminate and detach," according to the FDA.  

The FDA has categorized the recall as Class I, meaning that "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death," according to the Cleveland Plain Dealer.

The products in question were used for the "introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion," according to the FDA. Here is a full list of Medtronic products included in the recall. 

Medtronic began alerting customers on Oct. 21, requesting "all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement," the FDA said. 

Reuters posted Medtronics' response: "Medtronic spokesperson Joseph McGrath said the company started recalling 14,896 guidewires, or 181 lots, in the week of October 21, after receiving four complaints, including one patient injury, of the coating on the surface of the guidewires detaching." 

The company is not predicting severe financial consequences. "McGrath said the company does not expect the recall to have a material impact on its financial results. He said it had taken the necessary steps to prevent future shipments of the recalled products and had notified regulatory agencies around the world of the recall," the Reuters report said. 

Medtronics' most recent earnings report included positive news. "After a disappointing start for fiscal 2014, Medtronic managed to beat estimates in the second quarter of fiscal 2013," according to Zacks Investment Research, a financial analyst firm. 

The firm added that the severity of the recall is cause for "concern."