Arrow recalls specific models of UltraFlex Intra-Aortic Balloon Catheter Kits due to potential failure to inflate fully, damaged segments, or helium loss/blood in the pathway, which could cause serious health issues.
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
Arrow is recalling three specific models of UltraFlex Intra-Aortic Balloon Catheter Kits because they may not inflate properly or have damaged segments, which could lead to serious health problems. Affected units have unique serial numbers listed in the recall notice.
The catheter kits may fail to inflate completely over their full length, develop damaged or broken central lumens, or allow helium loss or blood in the helium pathway. These issues could lead to serious health consequences during medical procedures.
Healthcare professionals using these catheter kits for medical procedures are most at risk. Patients receiving treatment with the recalled kits could face serious health consequences if the issue occurs.
Check the product's serial numbers (UDI codes) listed in the recall notice. The affected kits have specific reference numbers (IAB-06830-U, IAB-06840-U, IAB-06850-U) with unique UDI codes starting with (01)10801902161939.
Look for the unique UDI codes listed in the recall notice to identify affected kits.
Arrow is recalling three specific models: REF IAB-06830-U, REF IAB-06840-U, and REF IAB-06850-U.
The catheter may not inflate fully, have damaged segments, or allow helium loss or blood in the pathway, which could cause serious health consequences.
Check the product's serial numbers (UDI codes) against the list provided in the recall notice.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1879-2024 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1879-2024 from Arrow. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
