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

The recall comes after reports of cracking at the distal catheter shaft, possibly resulting in patient injury.

Katie Hobbins, Managing Editor

April 8, 2024

1 Min Read
Medical Device Recall
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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.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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