Medtronic Aortic Root Cannulae and Cardioplegia Needles Recalled for Unsealed Sterile Packing
Medtronic is recalling aortic root cannulae and cardioplegia needles used in cardiac surgery due to potential unsealed sterile packaging. Approximately 2,622 units were distributed worldwide.
What this means for you
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: Risk-of-harm surgical devices with potential contamination risk from unsealed sterile packing. Meets criteria of risk-of-harm products where injury has not yet been reported, supported by FDA Class II classification and no confirmed illnesses or injuries.
Plain-English summary
Medtronic Perfusion Systems is recalling three models of surgical devices used in cardiopulmonary bypass procedures: the DLP 9 Ga Aortic Root Cannula (Model 24009), the DLP 16 Ga Cardioplegia Needle Neonatal (Model 11316), and the M+AR 14 Ga Aortic Root Cannula with Flow-Guard (Model 11014L).
The recall is due to the potential for unsealed sterile packing on affected units. This issue has been classified as an FDA Class II recall. Approximately 2,622 units have been distributed worldwide to medical facilities.
Healthcare facilities that have received affected units should contact Medtronic Perfusion Systems immediately for guidance. Lot numbers for affected units are documented in the FDA recall notice and available through Medtronic or the FDA website. Healthcare providers should verify whether their facility has received any affected units and take appropriate action.
The recalled product
- Product
- Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- unsealed-packaging
- contamination-risk
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 (20)
- a) Model Number 24009
- GTIN 00673978178646
- Lot Numbers: 2023040211
- 2023040854
- 2023041224
- a) Model Number 24009
- GTIN 20613994495420
- Lot Numbers: 2023031043
- 2023031563
- 2023040211
- 2023040480
- 2023040855
- 202305C108
- 202305C109
- 202306C196
- b) Model Number 11316
- GTIN 20613994676140
- Lot Numbers: 2023040437
- c) Model Number 11014L
- GTIN 20613994495499
Distribution
Distribution scope not specified by the agency.
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