Medtronic Perfusion Systems: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; 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 GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; 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 00643169454521, Lot Numbers: 0231545565, C231958117; GTIN 20643169454525, Lot Numbers: 0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716, 0231667178, 0231823613, 0231823689, 0231823700, 0231846134, 0231862819, 0231912810, C231958117, C231958118, C231958119, C231958120, C232287623.
- Product quantity
- 6572 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Brooklyn Park
- State
- MN
- Country
- United States
- Event id
- 98786
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