FDA Medical devices recall ·
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only recall
- Recall number
- Z-0978-2025
- Date
- (initiated December 16, 2024)
- Company / brand
- Integra LifeSciences Corp.
1100 Campus Rd, Princeton, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 170 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Why was it recalled?
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10381780535881. Lot Numbers: 7416790, 7432471, 7434929, 7434930, 7438312 and 7438313.
Distribution
US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.
States: Arizona California Colorado District of Columbia Florida Georgia Indiana Massachusetts Michigan Minnesota North Carolina Nebraska New Jersey New York Ohio Oregon Rhode Island South Carolina Texas Utah Virginia Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0978-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.