Official recall notice
FDA DeviceClass IINotable
FDA Recall: Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75
- Recall date
- 2026-05-27
- Category
- Medical Device
- 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.
Recommended action
What to do
589,223
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.