Medtronic Perfusion Systems: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Read the official notice at FDA (device) →
Get alerts for Medtronic Perfusion Systems
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 94913; 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 20643169454785, Lot Numbers: 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262, 0231772525, 0231792898, 0232066774, 0232112345, 0232114667, C232276641, C232277146, C232277149, C232949860, C232949864.
- Product quantity
- 3210 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Brooklyn Park
- State
- MN
- Country
- United States
- Event id
- 98786
Free daily digest + "My products" watchlist