DLP® 25010Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K182586, K831591); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1801-2024 · Root cause: Process control · FDA record ↗

2. Jun 22, 2017Terminated

   Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

   Z-2767-2017 · Root cause: Packaging process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182586, K831591. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2024 · Mar 19, 2024 · Open, Classified
  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
• Z-2766-2017 · Jun 22, 2017 · Terminated
  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