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
- Hazard
- device-malfunction
- monitoring-error
- physical-defect
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
Distributed in 50 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- WA
- WI
- WV
- WY
Related recalls
Same category
- SevereDexcom G7 Continuous Glucose Monitoring System sensors recalled
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- HighPhilips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
FDA (Devices) · 2026-07-01
- HighIntera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall
FDA (Devices) · 2026-07-01