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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic GUNDRY Retrograde Cannula

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 Class 2 Device Recall Medtronic GUNDRY Retrograde Cannulasee related information
Date Initiated by FirmApril 21, 2026
Date PostedMay 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2214-2026
Recall Event ID 98786
510(K)NumberK860149 K953945 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
ProductMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Code Information GTIN 00673978188447, Lot Numbers: 0231651336; GTIN 20643169454877, Lot Numbers: 0231651336, 0231651345, 0231651385, 0231651389, 0231651396, 0231667029, 0231667046, 0231757975, 0231758248, 0231758259, 0231936467, 0231982226, 0232274424, C232287618, C232287619, C232287620, C232598550, C232598552.
FEI Number 1000116158
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information ContactMedtronic Customer Service
800-854-3570
Manufacturer Reason
for Recall		Certain lots of product have the potential for a sterile barrier breach.
FDA Determined
Cause 2		Packaging process control
ActionMedtronic 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.
Quantity in Commerce3790 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DWF
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