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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for bleeding, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Arrow International, Inc., Division of Teleflex Medical Inc., is recalling the FiberOptix Ultra 8 IAB (8Fr 40cc; Product Code: IAB-05840-LWS). The recall involves 13,405 units in the US and 33,735 units outside the US. The devices were distributed nationwide in the US and in numerous countries worldwide, including Argentina, Australia, Belgium, and Canada.
The recall is due to a defect where the sheath body may become separated from the sheath hub. If this separation occurs, there is a potential for bleeding from the device. The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta to increase blood supply to the heart muscle and decrease the work of the left ventricle.
Healthcare providers and patients should contact Arrow International for further instructions regarding the recall and replacement of affected devices.
The recalled product
- 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
- Medical Device — Cardiovascular
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Arrow International, Inc., Division of Teleflex Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Arrow International, Inc., Division of Teleflex Medical Inc.
See all →- HighArrow UltraFlex IAB Recall for Potential Sheath Separation and Bleeding Risk
FDA (Devices) · 2016-03-16
- HighArrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding
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- CriticalArrow RediGuard IAB Recall Due to Sheath Separation Risk
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- HighArrow FiberOptix Ultra 8 IAB Recalled for Potential Sheath Separation
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- CriticalArrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation
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