The risk of serious injury or death has prompted a Class I recall on “some Medtronic devices used during heart procedures,” cites the U.S. Food and Drug Administration (FDA). To which, an estimated 15,000 devices are affected by the recall.
The recalled devices are guidewires – long thin wires – which are inserted through an artery and used to guide into place other devices such as stents, according to WebMD. The coating – called polytetrafluoroethylene or PTFE – is intended to help wires slide more easily – can detach and possibly block a blood vessel. The coating is included in many medical devices as well as nonstick cooking pans under the name Teflon.
The recall was issued in October after the medical device giant was notified of four problems which included one patient that suffered cardiac arrest but was resuscitated. Certain lots of guidewires, made since April, are involved in the recall. The company has halted all new shipments of the wires at this time and has also contacted regulators worldwide.
“The specific devices being recalled are “to facilitate percutaneous coronary interventions, or the placement of left ventricular leads for cardiac rhythm devices.”
For more information regarding this recall, please visit the FDA Website which is updated regularly with information. Customers can also contact Medtronic Lifeline Technical Support directly by calling 1-877-526-7890 Monday through Friday, 8 AM through 5 PM Central Standard Time.