Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Edwards Lifesciences, LLC is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters, Model 131HVF7P. These medical devices are used for hemodynamic monitoring in patients. The recall covers products distributed worldwide, including the United States, Canada, Japan, Europe, Asia Pacific, and Latin America.
The recall was initiated after the firm received multiple complaints regarding the passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. This issue involves the interaction between the catheter and the guidewire during use.
Healthcare providers and facilities that have received these devices should stop using them and contact Edwards Lifesciences for further instructions. Patients who have had these catheters used should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 32,145
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 59197000
- 59197001
- 59216091
- 59218827
- 59238961
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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