Thermodilution Catheter May Bend During Use, Causing Monitor Errors
Edward Lifesciences Swan-Ganz thermodilution catheters may bend during use, potentially causing patient monitoring devices to display error messages. The FDA has recalled 326 affected units distributed nationwide.
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: This FDA Class II recall involves a critical cardiac monitoring device where the potential for functional failure—bent catheter causing monitor error messages—poses a risk to patient monitoring. No illnesses or injuries have been reported.
Plain-English summary
Edward Lifesciences is recalling the Swan-Ganz CCOmbo V thermodilution catheter (Model REF 774F75, Lot 64526520). The distal end of affected catheters may be bent beyond their intended curvature.
When a bent catheter is connected to a patient monitoring device, the monitor may display an error message. The recall affects 326 units distributed nationwide.
Healthcare providers and facilities that received this device should verify their inventory and contact Edward Lifesciences with any questions.
The recalled product
- Product
- Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 326
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 (1)
- Primary DI Number: 00690103146998/ Lot: 64526520
Distribution
Part of a larger recall action
This product is one of 2 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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