FDA Device recall Z-1878-2024

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS

• FDA Device
• Class I
• ongoing
• Published 2024-06-12

On 2024-06-12 the FDA classified a Class I recall of Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS by Arrow International, citing teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest….

Read the official FDA Device notice

Product

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1878-2024%22

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