Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Assembly Error
Edwards Lifesciences is recalling 277 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class I recall, which by definition is unlikely to cause adverse health consequences. The defect results in incorrect diagnostic readings rather than direct physical injury.
Plain-English summary
Edwards Lifesciences, LLC is recalling 277 units of the Swan Ganz Thermodilution Catheter (REF131F 7J) due to a manufacturing defect. The affected products were distributed worldwide and include lot numbers 61321177 and 61227528.
The recall was initiated because the catheters have incorrect lumen assembly, which results in the reversal of the lumens. This defect causes the clinician to observe reversed pulmonary artery (PA) and central venous pressure (CVP) values and waveforms during use.
The Swan Ganz Thermodilution Catheter is a diagnostic tool used by physicians to determine hemodynamic pressures and cardiac output. Clinicians using these specific lots should verify their inventory against the provided lot numbers and contact the manufacturer for instructions on returning the affected devices.
The recalled product
- Product
- Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J 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 output computer.
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Catheter
- Affected units
- 277
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)
- Lot Numbers: 61321177
- 61227528
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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