Recall Z-1379-2023 ยท DYG Catheter, Flow Directed
Edwards Lifesciences, LLC
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)
| Date | Apr 12, 2023 (initiated Feb 14, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Packaging process control |
| Action | On March 10, 2023, Edwards issued a "Urgent Medical Device Correction" notification to affected consignees. In addition to informing consignees about the correction, Edwards ask consignees to take the following actions: Actions to be taken by customer 1. Review the customer letter for advice on action to be taken. 2. Please follow the instructions included in the enclosed acknowledgement form to complete the acknowledgement process. 3. Distribute this notice within your organization or to any organization where the potentially impacted product has been transferred. 4. Please post a copy of t |
| Quantity | 59,094 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.