Urgent Field Safety Notice For Swan-ganz True Size Thermodilution Catheter, Swan-ganz Pediatric Thermodilution Catheter, Swan-ganz Hi-shore True Size Thermodilution Catheter, Swan-ganz True Size Therm
Recall Summary Edwards Lifesciences is recalling several Swan-Ganz thermodilution catheters used to monitor heart function in patients, distributed in Germany and the EU. The specific reason for the recall is not clearly stated in the provided document. This is classified as a serious safety issue affecting multiple catheter models used in clinical settings.
- Recalling firm
- Urgent Field Safety Notice for Swan-Ganz True Size Thermodilution Catheter, Swan-Ganz Pediatric Thermodilution Catheter,
- Product
- s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for Swan-Ganz True Size Thermodilution Catheter, Swan-Ganz Pediatric Thermodilution Catheter, Swan-Ganz Hi-Shore True Size Thermodilution Catheter, Swan-Ganz True Size Thermodilutio Catheter "S-Tip",Swan-Ganz CCOmbo V CCO/SvO2/CEDV Th by Edwards Lifesciences LLC 2026
- Reason
- assessment Field corrective actions Urgent Field Safety Notice for Swan-Ganz True Size Thermodilution Catheter, Swan-Ganz Pediatric Thermodilution Catheter, Swan-Ganz Hi-Shore True Size Thermodilution Catheter, Swan-Ganz True Size Thermodilutio Catheter "S-Tip",Swan-Ganz CCOmbo V CCO/SvO2/CEDV Th by Edwards Lifesciences LLC 2026
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-04-17
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/ce875b01-a4e1-46b8-bdb5-69ed50fcc758