Medos’ Cerenovus Cerebase DA Guide Sheath Recall Categorized as Class I

Medos International Sàrl recently announced the recall of its Cerenovus Cerebase DA Guide Sheath after reports of cracking at the distal catheter shaft.

The guide sheath is categorized as a neurovascular catheter and is commonly used in procedures which require precise navigation and access to blood vessels in the brain. Designed to help deliver interventional devices into the blood vessels in the brain, the catheter allows for the placement of devices like stents or coils — treating neurovascular diseases and conditions.

The recall, identified as Class I by FDA, concentrates on complaints describing fractures of the distal catheter shaft. These potential cracks are found at the far end of the device that is placed into the brain, where different parts of the catheter join. Use of affected product, according to Medos, may result in surgical procedural delay, vascular injury or hemorrhage, and, in extreme rare occasions, embolism. The company has reported 3 injuries connected to the recall and no deaths.

On Feb. 2, Johnson & Johnson Medtech, on behalf of Medos, sent an Urgent Medical Device Recall to all affected customers, recommending they examine inventory and quarantine any recalled product, remove all recalled product, communicate the issue to anyone who needs to be informed, and contact any facility where affected products may have been forwarded to arrange return.

Currently, 1,343 devices have been recalled in connection with the issue. The affected devices were manufactured on July 7, 2023, and later, then distributed between June 14, 2023, and Dec. 14, 2023.