Medtronic Perfusion Systems: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medtronic Perfusion Systems
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
- Reason / hazard
- Certain lots of product have the potential for a sterile barrier breach.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-04-21
- Code info
- GTIN 00643169454460, Lot Numbers: 0231665646; GTIN 20643169454464, Lot Numbers: 0231665646, 0231665648.
- Product quantity
- 481 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Brooklyn Park
- State
- MN
- Country
- United States
- Event id
- 98786
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