FDA (Devices) recall action 85684
The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Arrow International Inc is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component vibration issue that may cause the device to stop working.
Arrow International Inc is recalling AC3 Optimus Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working or fail to start.
Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component vibration issue may cause the device to stop working or fail to start.
Arrow International is recalling AC3 Optimus Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working.
Arrow International is recalling AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working.
Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working or fail to start.
Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component issue that may cause the device to stop working.
Arrow International is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail, causing the device to stop working or fail to start.
Arrow International Inc is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component issue that may cause the device to stop working.
Arrow International is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail, causing the device to stop working or fail to start.