Cordis US Corp recalls Vista Brite Tip

Catheter manufactured at the incorrect length.

On February 7, 2025 Cordis issued a Urgent Medical Device Recall notification to affected consignees via E-Mail. Cordis asked consignees to take the following actions: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory for any units from the affected lot in your possession. 3. Identify and quarantine any units. Check all storage and usage locations. 3) Share this letter with others in your facility who need to be made aware of this recall and with any other facility. 4) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form or email to: GMB-CordisFieldAction@cordis.com 5) Return any affected product to the address listed on the form, with reference to your Customer Number which is listed on the form. 6) Maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice with the affected product.

• FDA enforcement recordOfficial FDA database entry for Z-1330-2025
• FDA 510(k) clearance · K021593The device's official FDA premarket clearance record
• FDA device classification · DQYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1250The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Cordis US CorpSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.