FDA Recalls 3 Heart Devices

FDA recalls Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters

(RxWiki News) The U.S. Food and Drug Administration has recalled three heart devices that could cause serious injury or death.

The FDA has recalled the Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters because the catheter tip could break off inside the patient and embolize causing tissue and blood vessel injury, heart attack or other serious complications requiring additional surgery.

"Discontinue use of these recalled devices immediately."

The catheters are used for ultrasound examination of coronary intravascular pathology on patients who are candidates for transluminal coronary interventional procedures.

Also recalled is the Terumo Coronary Ostia Cannula 10, 12 and 14 because fragments of adhesive and plastic in the cannula tip may embolize causing arterial injury, hemorrhaging or other serious problems. The device has been removed from the market and further devices will not be produced.

The Terumo Coronary Ostia Cannula is for use in delivering cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass.

Customers are asked to discontinue use and return products related to the Terumo Coronary Ostia Cannula, the Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters.

The third FDA recall involves the Maquet Datascope Corp. Intra-Aortic Balloon Pumps which can shut off without warning because a defective fan in the power supply may cause overheating. This could cause the device to stop operating without visible or audible alarms. Unanticipated interruption of therapy may cause the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events.

The intra-aortic balloon pump is an electromechanical system used to inflate and deflate an intra-aortic balloon to provide temporary support to the left ventricle of the heart during cardiac surgery. Customers are advised that their service representatives will arrange replacement of the power supply with a new fan assembly on affected devices.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online at: www.fda.gov/MedWatch/report.htm. A reporting form also is available by calling (800) 332-1088. The form can be returned by mail or fax.

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Review Date: 
June 14, 2011