FDA (Devices) recall action 73266

Arrow International, Inc., Division of Teleflex Medical Inc. recalled 9 products on 2016-03-16

The FDA (Devices) publishes a recall like this one as 9 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 9 pages.

Products: 9
Announced: 2016-03-16
Critical: 4
Units: —

Why these products were recalled

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

The agency’s own wording, quoted from the enforcement report.

1–9 of 9

HighFDA (Devices)··2016-03-16
Arrow FiberOptix Ultra 8 IAB recalled for potential sheath separation
Arrow International is recalling FiberOptix Ultra 8 IAB devices because the sheath body may separate from the hub, posing a risk of bleeding.
Product
FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decr
Category
Distribution
0 states
HighFDA (Devices)··2016-03-16
Arrow UltraFlex IAB Recall for Potential Sheath Separation and Bleeding Risk
Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
Category
Distribution
0 states
HighFDA (Devices)··2016-03-16
Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding
Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
Category
Distribution
0 states
CriticalFDA (Devices)··2016-03-16
Arrow RediGuard IAB Recall Due to Sheath Separation Risk
Arrow International is recalling RediGuard IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
Category
Distribution
0 states
HighFDA (Devices)··2016-03-16
Arrow FiberOptix Ultra 8 IAB Recalled for Potential Sheath Separation
Arrow International is recalling FiberOptix Ultra 8 IAB devices because the sheath body may separate from the hub, creating a risk of bleeding.
Product
FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventri
Category
Distribution
0 states
CriticalFDA (Devices)··2016-03-16
Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation
Arrow International is recalling Percutaneous Insertion Trays because the sheath body may separate from the hub, creating a potential for bleeding.
Product
Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work
Category
Distribution
0 states
SevereFDA (Devices)··2016-03-16
Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation
Arrow International is recalling specific Percutaneous Insertion Trays because the sheath body may separate from the hub, posing a risk of bleeding.
Product
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
Category
Distribution
0 states
CriticalFDA (Devices)··2016-03-16
Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding Risk
Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
Category
Distribution
0 states
CriticalFDA (Devices)··2016-03-16
Arrow UltraFlex IAB Recall: Sheath Separation Risk
Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
Category
Distribution
0 states