Edwards Lifesciences, LLC Recall 91868
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)
Edwards Lifesciences, LLC Recall 91868 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1380-2023 |
| Event ID | 91868 |
| Event 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) |
| Product Type | Devices |
| 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 |
| Recall 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. |
| Device Classification | 20230419 |
| Device Code Info | Primary DI Number: 00690103146998/ Lot: 64526520 |
| Center Classification Date | 20230412 |
| Recall Initiation Date | 20230214 |
| Recalling Firm | Edwards Lifesciences, LLC |
| Initial Notification | Letter |
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