(Reuters) – The U.S. Food and Drug Administration classified a recall of Teleflex’s inflatable devices that increase blood supply to the heart muscle as “most serious”.
Patients undergoing cardiac and non-cardiac surgery use these devices. They also treat heart failure and acute coronary syndrome.
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The company recalled 16,959 of its Arrow FiberOptix Intra-Aortic Balloon Catheter Kits and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits. A manufacturing error could cause the catheter’s inflatable balloon to become overtwisted, the regulator said.
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On Thursday, the FDA reported that Teleflex and its Arrow International unit had received 322 complaints. They added that 31 injuries and 3 deaths were potentially related to this issue.
Use of the device may cause serious injury, including blood loss, artery tears, unstable blood pressure, prevention of blood flow to the heart, or death, according to the FDA.
Moreover, the FDA Teleflex recall highlights significant health risks. These inflatable devices are used in surgeries and other medical interventions. Any malfunction could lead to severe complications or even fatalities. Therefore, the FDA urges hospitals and clinics to discontinue using these devices.
Furthermore, Teleflex is working closely with the FDA to manage this situation. They aim to address the issues causing these malfunctions promptly. For now, affected devices should be returned to the manufacturer. The FDA Teleflex recall serves as a reminder of the importance of rigorous quality control in medical equipment.
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