Medtronic Pediatric Arterial Cannulae Recalled for Incorrect Labeling
Medtronic is recalling 745 DLP Pediatric Arterial Cannulae (Models 77008 and 77014) due to incorrect labeling affecting seven manufactured lots distributed nationwide and 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 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: This is an FDA Class II recall involving labeling errors with no reported illnesses, injuries, or deaths. Labeling errors without reported harm are classified as moderate severity.
Plain-English summary
Medtronic Perfusion Systems is recalling 745 units of DLP Pediatric One-Piece Arterial Cannulae due to incorrect labeling affecting seven manufactured lots. The recall involves Model 77008 (8 Fr) with lot numbers 2024010723 and 202404C049, and Model 77014 (14 Fr) with lot number 2023121097.
The affected cannulae were distributed nationwide in the United States and worldwide. Healthcare facilities should verify their inventory against the specified lot numbers and models to identify any recalled units.
The recalled product
- Product
- DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- Affected units
- 745
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 (5)
- Model 77008 UDI-DI: 20763000091105
- Lot Numbers: 2024010723
- 202404C049
- Model 77014 UDI-DI: 20763000091136
- Lot Number: 2023121097
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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