Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector

The catheters may not retain their shape.

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113

Medtronic Cardiac Surgery issued an Urgent Medical Device Recall notice to its consignees on 08/06/2025 via UPS 2nd day delivery. The notice explained the issue with the device, potential harms if used, and requested the following: Customer Actions: Medtronic requests that you take the following actions: " Review your inventory for listed product. " Immediately identify and quarantine all unused, listed product in your inventory. " " " Please share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please notify the facility of this . " Please maintain a copy of this communication in your records. Although the issue has been corrected for newly manufactured lots, please be aware that Medtronic will have limited product availability for these items over the next few months. If the product is unavailable, you may work with your sales representative to explore potential replacement options that Medtronic can offer. Alternatively, Medtronic will issue a credit note if a suitable replacement is not available. For questions, please contact your Medtronic Field Representative.

• FDA enforcement recordOfficial FDA database entry for Z-2480-2025
• FDA 510(k) clearance · K834039The device's official FDA premarket clearance record
• FDA device classification · DWFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.4210The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medtronic Perfusion SystemsSearch 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.