Medtronic Recalls Guidewires Used in Heart Procedures
About 15,000 Medtronic devices used in heart procedures are being recalled by the company because they have defects that could result in serious injury or death, the U.S. Food and Drug Administration announced.
The recalled products are guidewires. They are inserted through an artery and used to guide into place devices such as stents, the Associated Press reported.
The recall was implemented Oct. 21 after Medtronic was informed about four problems, including one patient who suffered cardiac arrest but was resuscitated, according to company spokesman Joseph McGrath.
The coating on the recalled guidewires could break off and possibly block a blood vessel. The coating is meant to help the wires slide through blood vessels more easily, the AP reported.
The FDA has classified the recall as Class I, a category reserved for products with reasonable potential to cause serious injury or death.
The recall covers certain lots of guidewires made since April. Medtronic said it has halted new shipments of the wires and alerted regulators worldwide about the problem, the AP reported.