Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling 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 the hazard involves a mechanical defect in a medical device used for patient monitoring. While no specific injuries are reported in the text, the risk of harm from a device malfunction during a medical procedure places it in the High severity category.
Plain-English summary
Edwards Lifesciences, LLC is recalling its Swan-Ganz Thermodilution VIP Catheters, Model 131HF7J. These devices are used for hemodynamic monitoring in patients. The recall involves 32,145 units distributed worldwide, including the United States, Canada, Japan, Europe, Asia Pacific, and Latin America.
The recall was initiated because 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 could potentially affect the safe use of the device during hemodynamic monitoring procedures.
Healthcare providers and facilities that have received these catheters 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 about their procedure.
The recalled product
- Product
- Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Catheters
- 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 (7)
- 59174383
- 59174384
- 59216111
- 59219855
- 59233891
- 59247471
- 59252542
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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