A recall of medical guidewires by Medtronic, Inc. (NYSE: MDT) does not include any of the medical device maker’s pain pumps or spinal cord stimulators, according to a company spokesman.
On Friday, the Food and Drug Administration said the recently recalled guidewires, which are used in heart procedures, could potentially be fatal. The FDA classified 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.”
The problem stems from a coating on the wires that could detach, which could lead to a stroke or heart attack.
Medtronic began recalling nearly 15,000 of the guidewires in late October after receiving four complaints of the coating on the wire detaching, resulting in at least one patient being injured. Hospitals were notified to stop using the guidewires and to return them. All of the guidewires involved in the recall were made after mid-April of 2013.
“This does not pertain to spinal devices or to pain pumps. This is a guidewire that is used during surgical procedures to help implant certain cardiac devices like stents or implantable defibrillators,” Medtronic spokesman Chris Garland told National Pain Report.
“It’s not an implantable device. It’s only a tool that’s used to help implant devices. So patients need not worry.”
In June, the FDA declared a declared a Class I recall for one of Medtronic’s implantable pain pumps. The company identified defects in the SynchroMed implantable pain pump that caused the improper mixing of pain medications prior to injection into patients.
Although the defects were blamed for at least 14 deaths, the company did not recommend that the pump be removed. Over 200,000 SynchroMed devices have been implanted worldwide, according to Medtronic.