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.
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 risk of harm (bleeding) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Arrow International, Inc., Division of Teleflex Medical Inc., is recalling the FiberOptix Ultra 8 IAB (8Fr 30cc) intra aortic balloon counterpulsation device. 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 affected units were distributed worldwide, including in the United States and numerous international markets.
The source text does not specify specific instructions for consumers or healthcare providers regarding the immediate handling of these devices, nor does it report any specific injuries or illnesses associated with this defect.
The recalled product
- 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
- 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 FiberOptix Ultra 8 IAB recalled for potential sheath separation
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