The FDA is warning healthcare professionals and prospective patients that a February 2, 2024, recall of Cerenovus CEREBASE DA Guide Sheath has been labeled Class I, the most serious type, because use of the product may result in major injuries or death.
Initiated by Medos International Sàrl, the recall covers Cerenovus Cerebase DA Guide Sheath under part numbers GS9070SD, GS9080SD, GS9090SD, and GS9095SD, as well as the single-use Neurovascular guide catheter. Manufactured from July 7, 2023, and on, a total of affected 1,343 devices were distributed across the U.S. between June 14, 2023, and December 14, 2023.
Typically used in procedures that rely on precise navigation access to the brain’s blood vessels, the Cerebase DA Guide Sheath is a neurovascular catheter indicated to facilitate the placement of “interventional devices.” The product allows doctors to deliver devices such as stents or coils into the brain’s blood vessels during treatment of neurovascular diseases and related conditions.
Medos International Sàrl first took action after receiving complaints about fractures in the product’s distal catheter shaft. Due to a crack at the end of the catheter used for placement in the brain vessels, where multiple parts of the catheter meet, officials say that use of a defective product may put patients at risk for the following:
- delays in surgical procedures
- vascular injury or hemorrhage
- embolism, in very rare cases
At the time of the FDA announcement, the company has received three (3) reports of injury and no reports of death.
All impacted Medos customers received an Urgent Medical Device Recall notice sent by Johnson & Johnson MedTech on February 2, 2024. The following requests were outlined:
- Assess inventory for any products subject to the recall, and have any affected product quarantined.
- After removing the recalled product, communicate the issue to all relevant parties and personnel.
- If an affected product has been sub-distributed, contact that facility and arrange for the return of the item.
- After reading the letter, complete the Business Reply Form (BRF). To confirm receipt of the notice, scan and email the completed form to OneMD-Field-Actions@its.jnj.com, or have it faxed to (305) 265-6889, with Attention Line: Cerebase FA2350411.
- To return any inventory of CEREBASE DA Guide Sheath devices covered by the recall, read through instructions provided in the letter and call 1-844-483-3882 as soon as possible. Customers should note that the recalled products must be returned for a credit reimbursement.
As the FDA continues to monitor the recall, healthcare professionals and consumers alike are asked to report any adverse reactions and quality issues to the agency’s MedWatch reporting program.
If you or a loved one has suffered an adverse health outcome that can be traced to a compromised or mishandled medical device, your family deserves justice and maximum compensation. Our compassionate attorneys at TruLaw would like to learn about your case and help you fight for the best possible outcome. To learn more about how we can support you, connect with us online or take our free Instant Case Evaluation ℠.