DLP® 24009Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20613994495420), received between May 8, 2025 and Jul 10, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

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

3 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-1800-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SETUP FOR AORTIC ROOT MONITORING WITH THE DLP AORTIC ROOT CANNULAE WITH VENT LINE, THE STOPCOCK CAME OFF THE PRESSURE LINE WHEN CONNECTING IT TO THE MONITOR. THE EVENT OCCURRED AFTER THE ANTEGRADE NEEDLE HAD BEEN PLACED IN THE AORTA. THE CUSTOMER ASSUMED THAT THE GLUE IN THE LUER PORT HAD FAILED. THE STOPCOCK WAS MANUALLY REATTACHED AND SECURED IT WITH A SUTURE TO LAST FOR THE REMAINDER OF THE CASE. THE LINE WAS PRIMED AND CONNECTED TO THE MONITOR, AND CARDIOPULMONARY BYPASS WAS INITIATED. THE CASE WAS COMPLETED WITH THE SAME CANNULA, AND THE LINE WAS MONITORED THROUGHOUT THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470612 ↗
• MalfunctionJun 12, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DLP AORTIC ROOT CANNULA WITH A VENT LINE WAS ALLEGED TO HAVE A PRODUCT ISSUE IN WHICH THE NEEDLE IN THE CANNULA WAS TOO THIN RELATIVE TO THE CANNULA ITSELF, RESULTING IN THE PATH CREATED BY THE NEEDLE BEING TOO SMALL AND MAKING IT DIFFICULT TO INSERT THE CANNULA INTO THE TISSUE DURING USE. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192451 ↗
• MalfunctionJun 4, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF THESE DLP AORTIC ROOT CANNULAE WITH VENT LINE, THE USAGE OF THE DEVICES WAS DISCONTINUED DUE TO STRONG RESISTANCE AND THE POSSIBILITY OF REFLUX. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139936 ↗
• MalfunctionMay 8, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF 3 DLP AORTIC ROOT CANNULA WITH VENT LINE, IT WAS REPORTED THAT THE DEVICE WAS DISCONTINUED DUE TO STRONG RESISTANCE AND A POSSIBILITY OF REFLUX. THE 2 LEADS WERE OPENED AND 1 LEAD WAS NOT OPENED, BUT ALL WAS OF THE SAME LOT. 2 WAS USED, AND 1 WAS RETURNED UNUSED. THE DEVICE'S WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986677 ↗

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-1801-2024 · Mar 19, 2024 · Open, Classified
  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 Adapt
• Z-2767-2017 · Jun 22, 2017 · Terminated
  DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
• 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