Recall Z-1379-2023— Edwards Lifesciences, LLC
Class II · Ongoing
Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2023-02-14. FDA's recall record names no specific 510(k) clearance for this event. 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). Reason: There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-14
- Firm location
- Irvine, CA, United States
Product description
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)
Reason for recall
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
Data sourced from openFDA. This site is unofficial and independent of the FDA.