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.
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 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…
- 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 Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding
FDA (Devices) · 2016-03-16
- SevereArrow UltraFlex IAB Recall for Potential Sheath Separation and Bleeding Risk
FDA (Devices) · 2016-03-16
- CriticalArrow RediGuard IAB Recall Due to Sheath Separation Risk
FDA (Devices) · 2016-03-16
- SevereArrow FiberOptix Ultra 8 IAB Recalled for Potential Sheath Separation
FDA (Devices) · 2016-03-16
- CriticalArrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation
FDA (Devices) · 2016-03-16
Same hazard · bleeding
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