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 hazard involves a mechanical defect in a medical device used for patient monitoring where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Edwards Lifesciences, LLC is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters, Model 141HF7P. These medical devices are used for hemodynamic monitoring in patients. The recall covers products distributed worldwide, including the United States, Canada, Japan, Europe, the Middle East, Africa, 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. The affected units are identified by specific product codes, including 59174297, 59194298, and 59194299.
Healthcare providers and facilities should stop using the affected catheters and contact Edwards Lifesciences for instructions on how to return or replace the devices. Patients who have had these catheters inserted should consult their healthcare provider if they have concerns about their monitoring equipment.
The recalled product
- Product
- Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. 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 (10)
- 59174297
- 59194298
- 59194299
- 59197887
- 59203360
- 59203361
- 59207070
- 59219837
- 59247401
- 59247402
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.
See all 11 products in this recall →Related recalls
Same manufacturer · Edwards Lifesciences, LLC
See all →- ModerateEdwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
FDA (Devices) · 2026-05-20
- SevereFEM-FLEX II FEMII016A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI16 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II femoral arterial cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI18 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12