Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Reversal
Edwards Lifesciences is recalling 875 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it involves a significant defect in a medical device that could lead to serious health consequences.
Plain-English summary
Edwards Lifesciences, LLC is recalling 875 units of Swan Ganz Thermodilution Catheters, reference 131F7P (5 pack of 131F7). The affected lot numbers are 61321241, 61176369, 61176374, 61311580, 61176373, and 61321254. The products were distributed worldwide.
The recall is due to incorrect lumen assembly, which causes a reversal of the lumens. If the lumens are reversed, clinicians may observe reverse pulmonary artery (PA) and central venous pressure (CVP) values and waveforms. This defect affects the diagnostic accuracy of the device, which is used to determine hemodynamic pressures and cardiac output.
Healthcare providers should stop using the affected catheters and contact Edwards Lifesciences for further instructions. The recall is classified as Class I by the FDA.
The recalled product
- Product
- Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac o
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Catheter
- Affected units
- 875
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 (6)
- Lot Numbers: 61321241
- 61176369
- 61176374
- 61311580
- 61176373
- 61321254
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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