Medtronic Recalls DLP Cardioplegia Adapters Due to Packaging Pinholes
Medtronic Perfusion Systems is recalling DLP Cardioplegia Adapters with Pressure Port because small pinholes were identified in a single packaging configuration of sterile pouches.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the hazard is a packaging defect (pinholes) that compromises sterility. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Perfusion Systems is recalling the DLP Cardioplegia Adapter with Pressure Port. The recall was initiated after small pinholes were identified in a single packaging configuration of sterile pouches. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hours.
The recall affects a total of 63,053 units, including 48,180 units in the United States and 14,873 units outside the United States. The affected products are Model No. 15004, Product UPN 20613994900412, and include specific lot numbers: 2016031072, 2016031509, 2016050243, 2016081219, 2016100630, 2016120083, 2016120448, and 2017040113. The source text notes that a total of seven different products were affected by this packaging issue.
The products were distributed worldwide, including nationwide in the United States and in various foreign countries such as Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, and the United Kingdom. Healthcare facilities should stop using the affected units and contact Medtronic Perfusion Systems for further instructions.
The recalled product
- Product
- DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure…
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Cardiovascular
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 (10)
- Model No. 15004
- Product UPN 20613994900412
- Lot No. 2016031072
- 2016031509
- 2016050243
- 2016081219
- 2016100630
- 2016120083
- 2016120448
- 2017040113.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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.
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