Swan-Ganz Pacing Catheter, Models: D200F7 - 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.

Source: FDA | Recall date: 05/27/2026

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Affected product: Swan-Ganz Pacing Catheter, Models: D200F7

Summary: 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.

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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