The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1062-2016·Announced 2016-03-16

Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation

Arrow International is recalling specific Percutaneous Insertion Trays 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 recall is classified as FDA Class I, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. The specific hazard of potential bleeding from the device in a critical cardiac therapy context aligns with the 'Severe' criteria for significant injury risk.

Plain-English summary

Arrow International, Inc., Division of Teleflex Medical Inc., is recalling specific units of the Percutaneous Insertion Tray (Product Code: IAK-06845). The recall involves 13,405 units in the United States and 33,735 units outside the United States. The affected batches are 18F14A0037, 18F14B0040, 18F14E0027, 18F14F0027, and 18F14F0028.

The recall was initiated 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 Arrow IAB 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 affected products were distributed worldwide, including nationwide in the United States and in numerous other countries such as Argentina, Australia, Belgium, Brazil, Canada, China, India, Japan, and South Africa. Healthcare providers and facilities should check their inventory for the specific product code and batch numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.

The recalled product

Product
Percutaneous Insertion Tray; Product Code: IAK-06845 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…
Manufacturer
Arrow International, Inc., Division of Teleflex Medical Inc.
Category
Medical Device — Cardiovascular
Hazard

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 →

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