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Three recalls on defective CV devices announced
Maquet Datascope Corp., Boston Scientific and Terumo Cardiovascular Systems Corp., have each issued recalls on defective devices that, if used, could potentially lead to serious adverse events.
The first recall, which was sent in a letter to customers on March 17, was for the Maquet Datascope intra-aortic balloon pump that has a defective fan in the power supply that may cause overheating and shut down the device without alarm, according to a press release. Interruption of therapy could potentially lead to the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events.
The second recall was issued on the Terumo Coronary Ostia Cannula, which was intended for the direct delivery of cardioplegia solution to the coronary arteries during cardiopulmonary bypass. According to the release, foreign fragments of adhesive and plastic in the tip may embolize, causing arterial injury, hemorrhaging or other serious events requiring unplanned surgery. Terumo has removed the product line from the market and has discontinued further supply.
The last recall was for Boston Scientific iCross and Atlantis A SR Pro2 coronary imaging catheters. The catheters, which were designed for ultrasound examination of coronary intravascular pathology, have a tip that has been shown to break and embolize within the patient, causing tissue and blood vessel injury, MI or other serious events that could lead to unplanned surgery. The manufacturer notified customers of this defect on May 27, instructing them to discontinue use and return all products.
Recall notices containing affected model numbers for the Boston Scientific, Terumo and Maquet Datascope devices are available online.
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