Home / Brands / Arrow International, Inc., Division of Teleflex Medical
Arrow International, Inc., Division of Teleflex Medical Recalls
9 recalls on record · March 16, 2016 to March 16, 2016 · Medical Devices
March 16, 2016Medical DevicesFDA
Arrow International, Inc., Division of Teleflex Medical Inc. recalls Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsat
Hazard: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
March 16, 2016Medical DevicesFDA
Arrow International, Inc., Division of Teleflex Medical Inc. recalls Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsa
Hazard: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
March 16, 2016Medical DevicesFDA
Arrow International, Inc., Division of Teleflex Medical Inc. recalls RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation
Hazard: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
March 16, 2016Medical DevicesFDA
Arrow International, Inc., Division of Teleflex Medical Inc. recalls UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsa
Hazard: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
March 16, 2016Medical DevicesFDA
Arrow International, Inc., Division of Teleflex Medical Inc. recalls UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsa
Hazard: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
March 16, 2016Medical DevicesFDA
Arrow International, Inc., Division of Teleflex Medical Inc. recalls Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation
Hazard: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
March 16, 2016Medical DevicesFDA
Arrow International, Inc., Division of Teleflex Medical Inc. recalls FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic balloon cou
Hazard: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
March 16, 2016Medical DevicesFDA
Arrow International, Inc., Division of Teleflex Medical Inc. recalls Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation
Hazard: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
March 16, 2016Medical DevicesFDA
Arrow International, Inc., Division of Teleflex Medical Inc. recalls FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the
Hazard: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.