FDA Warns of Potential for Coating on Guidewires to “Delaminate and Detach”
The FDA alerted health care professionals of the potential for the coating of guidewires manufactured by Medtronic to “delaminate and detach,” which could result in patient injury or death. Nearly 15,000 of the devices were recalled in October after numerous complaints, including a patient injury. “The guidewires covered by this recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices,” noted the FDA. For a complete list of the affected products, read the FDA Alert.
Keywords: Death, Heart-Assist Devices, Percutaneous Coronary Intervention
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