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.
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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.
Intra-aortic Balloon Pump - News
Silver Spring, MD - Recent recalls of intra-aortic balloon pumps (IABPs), coronary ostia cannulae, and intravascular ultrasound (IVUS) catheters have been deemed by the FDA to be among the most urgent. The agency has categorized the recalls of Maquet
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
“Our Leonard is alive today and for that we thank Dr. Michael Heffernan and a very special piece of equipment called the intra-aortic balloon pump, which you helped purchase,” said Simpson to the audience. “The balloon was inserted through Leonard's
And on June 6, the agency announced a Class 1 recall for certain Datascope Corp. system intra-aortic balloon pumps because the devices may power down without warning. The recalled pumps may be manufactured with a defective power supply or may have had
4 In severe cases, advanced hemodynamic monitoring in order to titrate therapy, and intra-aortic balloon pump counterpulsation or other mechanical methods of left ventricular assistance have been advocated. Glucagon, in complementary doses to that of
FDA MedWatch – Maquet Datascope Corp. Intra-Aortic Balloon Pumps ...
ISSUE : A defective fan in the power supply may cause overheating and shut down the device without visible or audible alarms. Consequences of unanticipated interruption of therapy may include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events.
BACKGROUND : 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. See the recall notice for the affected lot/serial numbers of the devices are subject to this recall.
RECOMMENDATION : Maquet Datascope Corporation notified customers by letter on March 17, 2011 describing the problem, the potential hazard, and the action to be taken. Customers were advised that their Service Representative would arrange to replace the power supply on affected devices which would contain a new fan assembly.
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:
• Complete and submit the report Online: www.fda.gov/MedWatch/report.
Clinical Application of Intra-Aortic Balloon Pump: 
The Impella pump system is inserted percutaneously or via cutdown and might be a future alternative to intra-aortic balloon pump support.
Intra-Aortic Balloon Pump Therapy: 
: Bypass Graft w/ Vein; Insertion Intra Balloon Pump. What Are You Doing Today? !
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intra-aortic balloon pump n. A pump connected to a balloon device that is inserted into the descending aorta to provide temporary assistance to the
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