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 source text describes a mechanical defect (guidewire passage) that poses a risk of harm to patients, but no specific injuries or illnesses are reported in the provided text.
Plain-English summary
Edwards Lifesciences, LLC is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters, Model 131HF7P. These medical devices are used for hemodynamic monitoring in patients. The recall covers units distributed worldwide, including the United States, 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 could potentially affect the safety or performance of the device during use.
Healthcare providers and patients should check their inventory and records for the specific product codes listed in the recall notice. If the affected catheters are in use, they should contact Edwards Lifesciences for further instructions on replacement or return.
The recalled product
- Product
- Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. 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 (20)
- 59169527
- 59169528
- 59174318
- 59174320
- 59194314
- 59194315
- 59194316
- 59194317
- 59197004
- 59197005
- 59197006
- 59197007
- 59197008
- 59197009
- 59197010
- 59197897
- 59197898
- 59197899
- 59197900
- 59197901
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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