Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

The FDA is aware that Conavi has issued a letter to affected customers recommending certain Novasight Hybrid catheters be removed from where they are used or sold:

• Novasight Hybrid Catheter TA-06-0001
•  UDI-DI: (01)00628055603054
• Lot numbers: 230902, 240202, 240302, 240402, and 240502

What to Do

On March 12, 2025, Conavi sent all affected health care providers an Urgent Medical Device Product Removal notice recommending the following actions:

• Search your inventory for the affected product listed above and return to Conavi Medical Inc.

Reason for Recall

In one reported incident, the sheath of a Novasight Hybrid catheter detached during use and was left in the patient’s body. The full sheath was able to be removed from the patient without further injury.

Risks associated with the removal of a detached catheter sheath inside a coronary artery include coronary artery spasm, dissection, perforation, thrombosis, embolism, and abrupt vessel closure. In addition, during the removal process there may be hemodynamic consequences such as heart rhythm conduction disturbances (bradyarrhythmia and tachyarrhythmia), hypotension, and respiratory insufficiency. If retrieval strategies fail, emergent cardiac surgical intervention may be required.

Conavi has not reported any additional incidents or injuries associated with this issue.

Device Use

The Novasight Hybrid catheter is part of a system intended for intravascular imaging of coronary arteries.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact the firm at julie@conavi.com or (416)-483-0100 Ext 109.

Additional FDA Resources

• FDA Enforcement Report
• CDRH Medical Device Recall Database 

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Timeline of Communication Updates 

Date	Actions
01/05/2026	The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall.
04/18/2025	The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.