Arrow RediGuard IAB Recall Due to Sheath Separation Risk
Arrow International is recalling RediGuard 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 recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Arrow International, Inc., Division of Teleflex Medical Inc., is recalling the RediGuard IAB (7Fr 30cc; Product Code: IAB-S730C). The recall involves 13,405 units in the US and 33,735 units outside the US, distributed worldwide to numerous countries including Argentina, Australia, Belgium, and Canada.
The recall is 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 affected batches include specific lot numbers such as 18F14A0041, 18F14C0003, and 18F15M0009.
Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for instructions on return or replacement. This recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C 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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