Device product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
Z-2192-2012
Product summary
- Event
- Event 62278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,145 units for all products in Recall Event
- Official record key
device-enforcement:Z-2192-2012
Official wording
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Code information: 59197000, 59197001, 59216091, 59218827, 59238961
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).
Derived failure modes
-
Unknown
The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.