Arrow recalls specific models of FiberOptix Intra-Aortic Balloon Catheter Kits due to potential failure to inflate fully, damaged segments, or helium loss/blood in pathways, 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 FiberOptix Intra-Aortic Balloon Catheter Kits. These kits may not inflate properly, have damaged segments, or allow helium loss/blood in the pathway, which could lead to serious health consequences if not corrected promptly.
The catheter kits may fail to inflate completely over their full length, have damaged or broken central lumens within the balloon, or allow helium loss or blood to enter the helium pathway. If not identified and corrected quickly, these issues could cause serious health problems.
Healthcare professionals who use these catheter kits during medical procedures are most at risk. Patients receiving these kits during critical treatments could experience serious health issues if the problem isn't addressed.
Check the product reference codes: IAB-05830-LWS, IAB-05840-LWS, or IAB-05850-LWS. The unique device identifiers (UDIs) listed in the recall record can help identify affected units.
Verify your catheter kit's reference code (IAB-05830-LWS, IAB-05840-LWS, or IAB-05850-LWS) and unique device identifiers (UDIs) listed in the recall record.
The kits may fail to inflate completely over their full length, have damaged or broken central lumens within the balloon, or allow helium loss or blood to enter the helium pathway.
Check the product reference codes: IAB-05830-LWS, IAB-05840-LWS, or IAB-05850-LWS. The unique device identifiers (UDIs) listed in the recall record can help identify affected units.
No, but healthcare professionals should check the reference codes and UDIs to ensure they are using safe models. Affected kits should be corrected promptly if identified.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1878-2024 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1878-2024 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.
