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Open, Classified

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

FDA Recall Z-2214-2026 · Posted 2026-05-20

Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeDWF
Date Initiated2026-04-21
Product Quantity3790 units

Reason for Recall

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

Firm Action

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.

Root Cause

Packaging process control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETDlp, Inc. · 1996-03-26K860149VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015Dlp, Inc. · 1986-03-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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