DLP® 69324Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613994879213), received between May 14, 2025 and May 27, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT ANGLE METAL TIP, IT WAS REPORTED THAT CLOT WAS FOUND IN VENOUS CANNULA BY SURGEON UPON REMOVAL FROM THE SVC [SUPERIOR VENA CAVA] AND IVC [INFERIOR VENA CAVA]. DURING THE CASE ACTS [ACTIVATED CLOTTING TIMES] RANGED FROM 460-630 REQUIRING HEPARIN BOLUS ON BYPASS. IT WAS NOTED THAT PERIODICALLY DURING THE CASE THE HEART WOULD FILL UP POSSIBLY INDICATING A DRAINAGE ISSUE. THE CIRCUIT DID HAVE KVAD [KINETIC-ASSISTED VENOUS DRAINAGE] AND TOWARDS THE END OF THE CASE THE KVAD PRESSURES WERE TRENDING UP TO MAINTAIN APPROPRIATE EMPTYING. THE USE OF THE DEVICE WAS NOT SPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT BOTH A 20 AND 24 FRENCH CANNULA WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085875 ↗
• MalfunctionMay 14, 2025Contamination; Contamination

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE DLP SINGLE STAGE VENOUS CANNULAE WITH A RIGHT-ANGLE METAL TIP AND A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL CONTAMINATION ON THREE CANNULAE. IT WAS CONFIRMED DURING INSPECTION BY THE DISTRIBUTOR. THERE WAS A BLACK SPOT ON THE CANNULAE. THEY WERE UNOPENED. THE DEVICES WERE UNUSUED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017145 ↗