DLP® 71422Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169084548), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionMar 30, 2026Material Separation

  IT WAS REPORTED THAT, PRIOR TO CANNULATION USING THE DLP FLEXIBLE ARCH ARTERIAL CANNULA, THE DONUT COMPONENT WAS POSITIONED TOO FAR FROM THE TIP. IT WAS FURTHER REPORTED THAT WHEN THE PHYSICIAN ADJUSTED THE DONUT COMPONENT, IT WAS MOVEABLE. THE CANNULA WAS PUT ASIDE AND ANOTHER CANNULA FROM THE SAME BOX WAS OPENED AND USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710867 ↗

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.