Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling 32,145 units of 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 source text does not report any injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Edwards Lifesciences, LLC is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters, Model 131F7J. These devices are used for hemodynamic monitoring in patients. The recall covers units distributed nationwide in the United States and in various international regions, including Canada, Japan, EMEA, 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 is classified as an FDA Class II recall, indicating a reasonable probability that the use of the device could cause temporary or medically reversible health consequences.
Healthcare providers and facilities that have received these devices should stop using them and contact Edwards Lifesciences for instructions on how to return or dispose of the affected units. Patients who have had these catheters used should consult their healthcare provider if they have concerns about their monitoring.
The recalled product
- Product
- Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. 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 (2)
- 59243259
- 59263146
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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