Medtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94965) due to potential sterile barrier breach. The cannula is used in cardiopulmonary bypass procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text states only a potential for sterile barrier breach with no reported injuries or illnesses. Per the rubric, Class II recalls without hospitalization reports are typically scored at 2 (Moderate).
Plain-English summary
Medtronic Perfusion Systems is recalling certain lots of the Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965, a cardiopulmonary bypass vascular catheter. The affected lot numbers are 0231665658 and C231786900 (GTIN 20643169454815). A total of 260 units have been distributed worldwide.
The product has the potential for a sterile barrier breach, which could compromise the sterile integrity of the device. The cannula is distributed in the United States and internationally to Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
Healthcare facilities and providers in possession of affected lots should discontinue use and contact Medtronic Perfusion Systems for further guidance on this recall.
The recalled product
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- Affected units
- 260
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN 20643169454815
- Lot Numbers: 0231665658
- C231786900.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Medtronic Perfusion Systems
See all →- HighArterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
FDA (Devices) · 2026-08-05
Same hazard · sterile barrier breach
See all →- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27