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.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classified this recall as FDA Class I, which is defined as a situation where use of or exposure to a violative product may cause serious adverse health consequences or death.
Plain-English summary
Arrow International, Inc., Division of Teleflex Medical Inc., is recalling the Ultra 8 IAB (8Fr 40cc; Product Code: IAB-05840-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 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 agency has classified this recall as Class I.
A total of 13,405 units were distributed in the US and 33,735 units outside the US. The affected batches include 18F14B0044, 18F14B0045, 18F14E0060, 18F14F0019, 18F14G0067, 18F14H0002, 18F14J0026, 18F15A0033, 18F15B0009, 18F15B0019, 18F15C0012, 18F15D0016, 18F15D0037, 18F15D0044, and 18F15F0001. Distribution was worldwide, including the US and numerous international locations. Healthcare providers should contact the manufacturer for further instructions regarding the recall.
The recalled product
- 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…
- 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.
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