Medos International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. 

Recalled Product 

Product Names: 
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers:  

Neurovascular guide catheter, single-use 

Product Codes: QJP 
Manufacturing Dates: July 7, 2023, and later
Distribution Dates: June 14, 2023, to December 14, 2023 
Devices Recalled in the U.S.: 1,343
Date Initiated by Firm: February 2, 2024 
Device Use 

The CEREBASE DA Guide Sheath is a neurovascular catheter. This type of catheter is commonly used in procedures where precise navigation and access to blood vessels in the brain are required. This catheter is designed to help deliver interventional devices into the blood vessels in the brain, allowing doctors to place devices like stents or coils, to treat neurovascular diseases and conditions. 

Reason for Recall

Medos International Sàrl is recalling the Cerenovus CEREBASE DA Guide Sheath due to complaints describing fractures of the distal catheter shaft. This is a crack found in the far end of the catheter that is placed in the vessels in the brain, where different parts of the catheter are joined together.

The use of the affected product may result in surgical procedural delay, vascular injury or hemorrhage, and in extreme rare occasions it may result in embolism.  There have been 3 reported injuries.

There have been no reports of death.

Who May be Affected

Healthcare professionals who use the CEREBASE DA Guide Sheath in vascular procedures such as surgeries on the brain. 
People who are having procedures where precise navigation and access to blood vessels in the brain are required.
What to Do 

On February 2, 2024, Johnson & Johnson MedTech, on behalf of Medos, sent all affected customers an Urgent Medical Device Recall. 

The letter requested customers to: 

Examine inventory and quarantine any product subject to this recall.
Remove any product subject to this recall and communicate the issue to anyone who needs to be informed.
Contact any facility where affected products may have been forwarded to arrange their return.
Complete the Business Reply Form (BRF) confirming receipt of the notice and scan and email signed form to or fax it to (305) 265-6889.
Attention Line: Cerebase FA2350411

Follow instructions in the letter and immediately call 1-844-483-3882 to return any inventory of CEREBASE DA Guide Sheath devices subject to the recall. To receive credit reimbursement, customers must return product subject to the recall.
Attention Line: Cerebase FA2350411

Contact Information  

Customers in the U.S. with questions about this recall should contact Medos at 

Additional Resources  

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 using an online form, regular mail, or FAX. 


Content current as of:


Explore more

Stop Letting Others Control Your Life

Stop Letting Others Control Your Life

SUMMARY: In this episode, Brendon teaches… How to focus more on positive life outcomes like life satisfaction, fitness, happiness, and confidence is essential. Why better embracing significant...

You Asked: In a Woman with ADHD, Should You Continue Treatment...

Question: I have a 32-year-old patient with ADHD who stopped her stimulant medication (Concerta 54 mg) during pregnancy. She is now at 34 weeks of...

The Future of Period Pain Relief

Hey there, womanhood warriors! We get you, and we especially get you on those days of the month. Period cramps are a real problem...
Preventive Care: How It Can Save Your Business Money On Health Insurance

Preventive Care: How It Can Save Your Business Money On Health...

As a small business owner in California or Arizona, you already understand the importance of keeping your employees healthy and productive. But you also...

Biosensor technology company Allez Health secures $60M

California-based Allez Health, formerly Zense-Life, announced it secured $60 million in Series A+ financing.  The round was led by strategic investor Osang Healthcare, with participation...
Omega-3 index test

Omega-3 index test and benefits for overall health and well-being

The Omega-3 Index test...
Thousands of NÜTRL tumblers recalled after dozens report illness - National

Thousands of NÜTRL tumblers recalled after dozens report illness – National

A promotional NÜTRL branded tumbler that was recalled in Canada earlier this month caused multiple reports of adverse health effects, an updated notice said...
Dentistry procurement platforms and trends 2024

E-Procurement Platforms, AI, and More Trends from DentalForum 2024

This article was written by the Planet DDS staff and originally published on this year’s DentalForum, leaders from more than two dozen dental...