OCT and IVUS imaging catheters of coronary arteries withdrawn for safety issues
OCT and IVUS imaging catheters of coronary arteries withdrawn for safety issues:
1. FDA Warning:
The U.S. FDA issued a safety alert regarding catheters used with Conavi Medical’s Novasight Hybrid System.
2. Recall Status:
No official recall yet, but certain catheter lots are being voluntarily removed from the market.
3. Device Use:
The Novasight Hybrid System is designed for OCT and IVUS imaging of coronary arteries.
4. Incident Triggering Alert:
A catheter sheath detached during use and was left inside a patient’s body, though it was successfully removed without further injury.
5. Potential Risks:
• Coronary artery complications (e.g., spasm, dissection, perforation)
• Thrombosis, embolism, or abrupt vessel closure
• Hemodynamic issues: arrhythmias, hypotension, respiratory insufficiency
• May require emergency cardiac surgery if retrieval fails
6. No Additional Cases Reported:
As of now, this is an isolated incident.
7. Company Action:
In March, Conavi Medical sent an Urgent Medical Device Product Removal notice to all affected healthcare providers, asking them to return unused products.
8. Next Steps for Providers:
Healthcare providers are advised to monitor the FDA website for updates.
9. FDA Review Ongoing:
The FDA is still evaluating the situation and will issue further guidance if a full recall is necessary.
10. Affected Lot Numbers:
• 230902
• 240202
• 240302
• 240402
• 240502