Agency classClass IIOur severity:High FDA (Devices)·Z-1379-2023·Announced 2023-04-19

Swan-Ganz Thermodilution Catheter May Bend and Cause Monitor Error

Edwards Lifesciences is recalling Swan-Ganz CCOmbo V thermodilution catheters because the distal end may bend beyond its intended curvature, potentially causing the patient monitoring device to display an error message.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device where the distal end may bend beyond intended curvature, potentially causing monitoring device malfunction. This is a risk-of-harm product where injury has not been reported, and the hazard is theoretical based on product design defect.

Plain-English summary

Edwards Lifesciences, LLC, is recalling the Swan-Ganz CCOmbo V thermodilution catheter, model REF 777F8, with exterior diameter 8F (2.7mm) and usable length 110 cm. Approximately 59,094 units have been distributed nationwide across all U.S. states and the District of Columbia.

The distal end of the catheter may bend beyond its intended curvature. When connected to a patient monitoring device, this bending may cause the monitor to display an error message.

Healthcare facilities and providers using this catheter should check their inventory against the specific lot numbers listed in the FDA recall notice. If you have catheters matching the affected lots, discontinue use and contact Edwards Lifesciences or the FDA for guidance on replacement or return.

The recalled product

Product: Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Hemodynamic Monitoring Catheter
Hazard: catheter-defect
device-malfunction
Affected units: 59,094

Distribution

Distributed in 50 states:

Part of a larger recall action

This product is one of 2 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Edwards Lifesciences, LLC

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Same hazard · catheter defect