Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation
Arrow International is recalling Percutaneous Insertion Trays 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 states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical).
Plain-English summary
Arrow International, Inc., Division of Teleflex Medical Inc., is recalling the Percutaneous Insertion Tray (Product Code: IAK-S7IT). The recall involves 13,405 units in the United States and 33,735 units outside the United States, distributed worldwide.
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 affected batches are 18F14A0037, 18F14B0040, 18F14E0027, 18F14F0027, and 18F14F0028.
This product is utilized for intra-aortic balloon counterpulsation therapy. Healthcare providers and patients should check their inventory and discontinue use of the affected trays. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Percutaneous Insertion Tray; Product Code: IAK-S7IT 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
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch: 18F14A0037 18F14B0040 18F14E0027 18F14F0027 18F14F0028
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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