Official recall notice

FDA DeviceClass IINotable

Swan-Ganz Pacing Catheter Models Recall (May 2026) – Becton

Product: Swan-Ganz Pacing Catheter, Models: D200F7;

Recall date
2026-05-27
FDA class
Class II

Why it was recalled

Hazard

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

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Product description

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

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