DLP® 70422Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169485918), received between Feb 21, 2025 and Feb 21, 2025 — classified as 1 malfunction.

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.

• MalfunctionFeb 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP FLEXIBLE ARCH ARTERIAL CANNULA, IT WAS REPORTED THAT THE DEVICE WAS LEAKING ONCE THE CANNULA WAS PLACED FOR BYPASS. THE WHITE LUER CAP WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. PATIENT BLOOD LOSS WAS MINIMAL, AP PROXIMATELY 2ML. AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK DID NOT OCCUR IN THE CANNULA ITSELF. IT OCCURRED IN THE WHITE LUER CAP. AS A RESULT, THE WHOLE CANNULA WAS NOT REPLACED BUT JUST THE CAP. THEREFORE, THE INSERTION SITE WAS NOT CHANGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21431056 ↗

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.