Arrow UltraFlex IAB Recall: Sheath Separation 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 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 source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
Arrow International, Inc., Division of Teleflex Medical Inc., is recalling the UltraFlex IAB (7.5Fr 30cc; Product Code: IAB-06830-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 issued 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 agency has classified this recall as Class I.
A total of 13,405 units were distributed in the US and 33,735 units were distributed outside the US. The affected batches include 18F13M0016, 18F14A0017, 18F14A0018, 18F14A0022, 18F14A0046, 18F14E0054, 18F14E0070, 18F14G0038, 18F14G0078, 18F14H0007, 18F14J0007, 18F14J0025, 18F14K0016, 18F15A0035, 18F15B0006, 18F15B0014, 18F15C0019, 18F15E0028, 18F15F0016, 18F15G0007, 18F15H0009, and 18F15H0035. Distribution was worldwide, including the US and numerous international markets.
The recalled product
- Product
- UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-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.
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Same hazard · bleeding
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