Medtronic Cardioplegia Adapters recalled for potential unsealed sterile packaging
Medtronic is recalling seven models of cardioplegia adapters due to potential unsealed sterile packaging, which could compromise equipment sterility in cardiac surgery. No illnesses have been reported.
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: This is an FDA Class II recall of medical devices used in critical cardiac surgery where compromised sterile packaging poses a risk of contamination-related infection. No injuries or illnesses have been reported, and the hazard is theoretical rather than confirmed.
Plain-English summary
Medtronic Perfusion Systems is recalling seven models of DLP cardioplegia adapters used in cardiac perfusion systems. The adapters may have unsealed sterile packaging, which could allow contamination of the medical equipment. The affected models are: DLP 1.8 m Pressure Monitoring Extension Line Adapters (Models 25009 and 25010), DLP Multiple Perfusion Sets (Models 14003 and 14000), DLP 50.8 cm Extension Line Adapter (Model 11001G), DLP Perfusion/Venting Adapter (Model 13002), and DLP Y Adapter Coronary Perfusion (Model 10710). A total of 6,290 units have been distributed worldwide.
Cardioplegia adapters are critical components used during cardiac bypass surgery to deliver specialized solutions to the heart. If sterile packaging is compromised, the adapters could become contaminated, potentially increasing the risk of infection during surgical use.
Healthcare facilities and healthcare providers currently using these adapters should verify whether they have received affected units by checking the model numbers and lot numbers provided by the manufacturer. Medtronic has provided detailed lot number and GTIN information to assist in identifying affected product. Healthcare facilities should contact Medtronic directly for instructions on replacement or return of recalled units.
No illnesses or injuries related to this recall have been reported to date.
The recalled product
- Product
- Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003,
- 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 25009
- GTIN 20613994918608
- Lot Numbers: 2023040212
- 202305C110
- b) Model Number 25010
- GTIN 20613994918585
- Lot Numbers: 2023041227
- 202305C111
- c) Model Number 14003
- GTIN 00613994619662
- Lot Numbers: 2023040464
- c) Model Number 14003
- GTIN 20613994619666
- Lot Numbers: 2023040463
- 2023040464
- 202305C102
- d) Model Number 14000
- GTIN 00613994619716
- Lot Numbers: 2023041205
- 2023041206
Distribution
Distribution scope not specified by the agency.
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