The FDA has announced a critical recall of the Novasight Hybrid catheters, manufactured by Conavi Medical Inc., due to safety concerns. This recall affects specific batches of the product distributed for intravascular imaging of coronary arteries. Clinical, quality, and regulatory teams are advised to review this recall with urgency, as the FDA has classified it as the most serious type, indicating potential risks of serious injury or death if the device is used.
What changed?
Conavi Medical Inc. issued an Urgent Medical Device Product Removal notice on March 12, 2025. The recall directs healthcare providers and facilities to locate and return specific lot numbers of the Novasight Hybrid catheter. The affected lot numbers include:
- 230902
- 240202
- 240302
- 240402
- 240502
The recall also provides guidance on contacting Conavi Medical directly with any questions or for assistance in returning the affected devices. For reference, the unique device identifier (UDI-DI) for the recalled products is (01)00628055603054.
Why was the recall issued?
The recall was initiated due to reports of the catheter sheath detaching during use, which raises significant safety concerns. In one reported case, the detached sheath was left inside the patient’s coronary artery during a procedure. Fortunately, the sheath was successfully removed without further complications.
However, risks associated with such incidents include serious medical complications, such as:
- Coronary artery spasm
- Dissection
- Perforation
- Thrombosis
- Embolism
- Vessel closure
Additionally, during the sheath removal process, patients may experience hemodynamic disturbances such as irregular heart rhythms, lowered blood pressure, or respiratory failure. In extreme cases, if the retrieval fails, emergency cardiac surgery may be required. Conavi has stated that no further incidents or injuries have been reported to date.
Who is affected?
This recall primarily affects healthcare providers and facilities in the United States that use or distribute the Novasight Hybrid catheter system for intravascular imaging. Providers are urged to immediately search their inventories for the affected lot numbers and discontinue using the recalled devices. Adverse reactions or quality problems encountered with this device should be reported to the FDA through the MedWatch program.
How to take action
Healthcare providers and distributors should follow these steps:
- Locate all affected Novasight Hybrid catheters in your inventory using the lot numbers listed above.
- Immediately halt further use of these devices.
- Return the recalled devices to Conavi Medical Inc. via the contact provided below:
Email: julie@conavi.com
Phone: (416)-483-0100 Ext 109
Device purpose and benefits
The Novasight Hybrid catheter is designed for diagnostic imaging within coronary arteries, supporting physicians in identifying and treating cardiovascular conditions. The device uses imaging technology to provide high-resolution intravascular views. Despite its intended benefits, the reported risks associated with the detached sheath have compelled the manufacturer and the FDA to issue the recall to ensure patient safety.
How to report problems
If you or your organization has experienced adverse reactions, complications, or technical issues while using this device, please report them to MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Accurate reporting of issues will aid in risk management and enhance overall safety measures for future usage.
Conclusion
The FDA’s recall of the Novasight Hybrid catheters underscores the critical importance of ensuring medical device safety. Healthcare providers should act immediately to remove affected devices from use and report adverse events to aid in mitigating risks. Stay informed by following updates from the FDA and contacting Conavi Medical for additional assistance.
Disclaimer
This content is intended for informational use by clinical, quality, and regulatory professionals. It does not constitute legal or medical advice. For specific guidance, consult your organization’s compliance team or legal counsel.
Mandatory FDA Information
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/diagnostic-intravascular-catheter-recall-conavi-removes-novasight-hybrid-catheters