Arrow recalls specific Ultra 8 IAB Intra-Aortic Balloon Catheter Kits due to potential failure to inflate fully or damage in the balloon segment, 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 two specific models of Ultra 8 IAB Intra-Aortic Balloon Catheter Kits that may not inflate properly or have damaged segments, risking serious health problems during medical procedures.
The catheter kits may fail to inflate completely over their full length or develop damaged segments, potentially leading to serious health consequences if not corrected before use. This issue could occur during medical procedures requiring precise balloon function.
Healthcare professionals using the recalled catheter kits for medical procedures are most at risk, particularly during critical treatments where proper function is essential.
Check for model references IAB-05830-U or IAB-05840-U on the packaging or product labels. The unique device identifiers (UDIs) listed in the recall notice can help identify affected units.
Look for model references IAB-05830-U or IAB-05840-U on the packaging or product labels.
Reach out to Arrow International for guidance on whether your specific unit is affected and next steps.
The recalled models are IAB-05830-U and IAB-05840-U.
Check for model references IAB-05830-U or IAB-05840-U on the packaging or product labels. The unique device identifiers (UDIs) listed in the recall notice can help identify affected units.
Contact Arrow International for guidance on whether your specific unit is affected and next steps.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1880-2024 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1880-2024 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.
