Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
UltraFlex IAB: 7.5Fr 40cc Recalled by Arrow International, Inc., Division of Teleflex Medical Inc. Due to The sheath body may become separated from the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arrow International, Inc., Division of Teleflex Medical Inc. directly.
Affected Products
UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-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 of the left ventricle.
Quantity: 13,405 US and 33,735 OUS in total
Why Was This Recalled?
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Arrow International, Inc., Division of Teleflex Medical Inc.
Arrow International, Inc., Division of Teleflex Medical Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report