FDA (Devices) recall action 91021
The FDA (Devices) publishes a recall like this one as 31 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 31 pages.
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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 AutoCAT2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The recall affects 12 units distributed worldwide.
The Arrow AutoCAT2 intra-aortic balloon pump has been recalled due to potential short battery run-times. This Class I recall affects devices distributed worldwide.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.
Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.
Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times.
Arrow AutoCAT 2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. Affected users should contact the manufacturer for guidance.
Arrow AutoCAT2WAVE intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The Class I recall affects 48 units distributed worldwide.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times. All lot and serial numbers worldwide are affected.
Arrow International recalls AC3 Optimus intra-aortic balloon pumps worldwide due to short battery run-times. The FDA issued a Class I recall affecting all lot and serial numbers.
Arrow AutoCAT2WAVE IABP devices have been recalled due to a potential issue with short battery run-times. The recall covers 112 units distributed worldwide.
Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide are being recalled due to short battery run-times. All lot and serial numbers are affected.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times that could affect the device's ability to provide continuous cardiac support.
Arrow AutoCAT2WAVE intra-aortic balloon pumps are being recalled for a potential issue with short battery run-times. The FDA Class I recall affects 39 units distributed worldwide, manufactured by Arrow International Inc.
Arrow International is recalling 127 units of the AutoCAT2WAVE Intra-Aortic Balloon Pump worldwide due to a potential issue with battery runtime.
Arrow International is recalling 6 refurbished Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times. The affected devices may not operate for sufficient duration during medical use.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pumps are being recalled worldwide due to short battery run-times affecting device operation. Patients using this device should contact their healthcare provider immediately.
Arrow AutoCAT2 intra-aortic balloon pumps may experience shorter battery run-times than specified, affecting device reliability in cardiac care. The FDA has issued a Class I recall for all affected units worldwide.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.
The Arrow AutoCAT2WAVE intra-aortic balloon pump is being recalled worldwide due to a potential issue with short battery run-times. Healthcare facilities should contact the manufacturer for guidance.
Arrow International is recalling 88 units of Arrow AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. Affected cardiac support devices may not operate reliably.
Arrow International is recalling Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices worldwide due to a potential issue with short battery run-times.
Arrow International is recalling the AutoCAT2 intra-aortic balloon pump (model AEROAUTOCAT 2 WAVE) due to a potential issue with short battery run-times that may affect patient cardiac support.
Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP) devices are recalled worldwide due to a potential issue with shortened battery run-times. All lot and serial numbers of model IAP-0700 are affected.
Arrow AC3 Optimus Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. The FDA issued a Class I recall for these devices.
The Arrow AutoCAT2WAVE intra-aortic balloon pump is recalled due to a potential issue with short battery run-times. The FDA Class I recall affects 4 units distributed worldwide.