FDA Enforcement
Class II
Ongoing
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
Recall: Z-1380-2023
·
Reported April 19, 2023
Enforcement
- Recall Number
- Z-1380-2023
- Event ID
- 91868
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Edwards Lifesciences, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 19, 2023
- Initiation Date
- February 14, 2023
- Classification Date
- April 12, 2023
- Address
- 1 Edwards Way, N/A, Irvine, CA, 92614-5688, United States
Description
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 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.
Code Info
Primary DI Number: 00690103146998/ Lot: 64526520
Distribution
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None
Quantity
326 units