The Recall Desk
ModerateFDA (Devices)·Z-0984-2025·Announced 2025-01-29

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.

What this means for you

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
Category
Medical Device — Perfusion Device
Hazard
  • mis-labeling

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.

Related recalls

Same category