HIGH
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Systems
Certain lots
HIGH
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
Quick Facts at a Glance
- Recall Date
- April 21, 2026
- Hazard Level
- HIGH
- Brand
- Medtronic Perfusion Systems
- Geographic Scope
- 1 states
Hazard Information
Certain lots of product have the potential for a sterile barrier breach.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic Perfusion Systems or your healthcare provider for instructions. Notification method: Letter
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Full Description
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter. Reason: Certain lots of product have the potential for a sterile barrier breach.. Classification: Class II. Quantity: 3790 units. Distribution: 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.
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Product Classification
Product Details
Categories
Model Numbers
GTIN 00673978188447
Lot Numbers: 0231651336
GTIN 20643169454877
0231651345
0231651385
+14 more
Affected States
ALL
Report Date
May 27, 2026
Source Agency
FDA - Medical DevicesRecall Status
ACTIVE
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