Medtronic Perfusion Systems recalls DLP Pediatric One-Piece Arterial Cannulae

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)

An URGENT: MEDICAL DEVICE RECALL notification letter dated 12/12/24 was sent to customers. Patient Recommendations: Patients previously supported with an impacted device face no additional risk from the issue described in this communication and should continue to be monitored per your practice s normal follow-up procedures. 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. " Return unused, listed product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as necessary. " Complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have any affected product in your possession. " 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. If you have any questions regarding this communication, please contact your Medtronic Field Representative.

• FDA enforcement recordOfficial FDA database entry for Z-0984-2025
• FDA 510(k) clearance · K024069The 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.