FDA confirms new recall after catheter sheath was left in patient’s body
The U.S. Food and Drug Administration (FDA) has finalized a new recall of the catheters associated with Conavi Medical’s Novasight Hybrid System after the sheath of one device became detached during use and was left in the patient’s body. The device is an intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging system where the two modalities are combined into one catheter.
This is a Class I recall, which means using the devices could result in a serious injury or death.
The FDA first shared a warning about this issue in April 2025. At the time, the agency was still evaluating the situation and no recalls had been announced. Now, however, the Class I recall has been made official.
Image courtesy of the FDA's early alert.
What customers should know about this Class I recall
The Novasight Hybrid System is used for the intravascular imaging of a patient’s coronary arteries. In one case, the catheter became detached and had to be retrieved. The FDA did emphasize that the catheter was safely removed without any additional injuries.
“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,” according to the agency. “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 Medical has sent letters to all customers highlighting this issue and recommending that certain Novasight catheters be removed from where they are used or sold. Lot numbers included in this alert were 230902, 240202, 240302, 240402 and 240502.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.