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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device."
Plain-English summary
Arrow International, Inc., Division of Teleflex Medical Inc., is recalling the UltraFlex IAB (7.5Fr 40cc, Product Code: IAB-06840-U). This medical device is utilized for intra aortic balloon counterpulsation therapy in the aorta, where balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
The recall is being conducted because the sheath body may become separated from the sheath hub. If this separation occurs, there is a potential for bleeding from the device.
The recall affects 13,405 units in the US and 33,735 units outside the US, with worldwide distribution including the US (Nationwide) and numerous international countries. Specific batch codes are listed in the agency's structured data. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- 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…
- 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 →- SevereArrow FiberOptix Ultra 8 IAB recalled for potential sheath separation
FDA (Devices) · 2016-03-16
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- CriticalArrow RediGuard IAB Recall Due to Sheath Separation Risk
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- CriticalArrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation
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Same hazard · bleeding
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