DLP® 70424Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169485925), received between May 27, 2025 and May 27, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 other recall cover devices cleared under the same FDA submission (K840001); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP FLEXIBLE ARCH ARTERIAL CANNULA, IT WAS REPORTED THAT THERE WAS A LEAKAGE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER SUTURED THE DEVICE TO STOP THE LEAK. THE LEAK IS FROM THE CANNULA. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE CANNULA TIP WAS DAMAGED. THE AMOUNT OF PATIENT BLOOD LOSS COULD NOT BE PROVIDED. A TRANSFUSION WAS REQUIRED BUT NOT BECAUSE OF THE LEAK. THE CANNULA WAS EXPERIENCING INSTABILITY IN THE BEARING (TIP OF THE CANNULA) WHICH CAUSED LEAKAGE DURING AORTIC CANDATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22086157 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K840001. One submission often covers many models, so check the product and lot details in each record.

• Z-1925-2008 · May 9, 2008 · Terminated
  Medtronic Arterial Cannula Straight Beveled tip, for Cardiopulmonary Bypass. Catalog Numbers: CB71424, CB77008, and CB77010.