This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
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.
- Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Early Alert
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.
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 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.
