Medtronic DLP Coronary Ostial Cannulae recalled for potential unsealed sterile packing
Medtronic recalled 250 units of DLP Coronary Ostial Cannulae (Model 30050) due to potential unsealed sterile packing. Lot 2023070529 was distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving surgical instruments with potential sterility compromise. The hazard—unsealed sterile packing—creates a risk of infection during surgical use. No illnesses or injuries have been reported, meeting the criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling the DLP Coronary Ostial Cannulae, Model Number 30050. These surgical instruments are used in cardiac bypass procedures. The recall affects 250 units with lot number 2023070529 that were distributed worldwide.
The hazard identified is potential for unsealed sterile packing. Sterile surgical instruments must be maintained in sealed, sterile packaging to prevent contamination. If the sterile packing is not properly sealed, the instruments may become contaminated and could pose an infection risk if used in patients.
The recalled product
- Product
- Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 250
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 00613994576019
- Lot Numbers: 2023070529
- GTIN 20613994576013
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 13 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 13 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
Similar recalls
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Aortic Root Cannula Recalled for Potential Sterility Breach
FDA (Devices) · 2024-11-13
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27