Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter p
FDA device recall Z-0765-2019 · posted 2019-01-31 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.
- Action taken
- An Urgent Product Recall letter was sent via Fed-Ex to affected customers on 12/21/2018. A second communication was sent via Fed-Ex on 01/10/19. The letter identified the affected product, problem and actions to be taken. Customers were instructed to the return any unused units that are currently in their inventory. Once returned, replacement product will be shipped at no charge. Customers were asked to complete the attached acknowledgement form. For questions contact Technical Support at 1-800-822-8837 option 1.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DYG
- Quantity affected
- 459 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2018-12-21
- Date posted
- 2019-01-31
- Date terminated
- 2023-11-02
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Swan Ganz Catheters (K160084) | Edwards Lifesciences, LLC | 2016-05-03 |