Recall
FDAHealthApril 21, 2026

Medtronic Perfusion Systems — Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
April 21, 2026

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.

What's affected?

Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Lot code
0231757977

Additional details

GTIN 20643169454785, Lot Numbers: 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262, 0231772525, 0231792898, 0232066774, 0232112345, 0232114667, C232276641, C232277146, C232277149, C232949860, C232949864.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 3210 units.

View original FDA notice →

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