Medtronic Perfusion Systems recalls Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR

Certain lots of product have the potential for a sterile barrier breach.

Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter

Medtronic Cardiac Surgery issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 4/21/2026 via UPS. The notice explained the issue, potential risk. and requested that the affected product be returned by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return for credit or replacement product. Consignees were directed to share this notification with others in your organization as appropriate. If the product listed above has been forwarded to another facility, please notify the facility. For questions regarding this communication, consignees were asked contact their Medtronic representative.

• FDA enforcement recordOfficial FDA database entry for Z-2214-2026
• FDA 510(k) clearance · K860149The device's official FDA premarket clearance record
• FDA 510(k) clearance · K953945The 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.