DLP™ CB77016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000192860), received between Jun 12, 2023 and Jun 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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. 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.

• MalfunctionJun 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, THE CUSTOMER REPORTED A LEAKAGE AROUND THE LUER LOCK. THE CUSTOMER CUT THE CANNULA JUST BEFORE THE LUER LOCK AND MADE THE CONNECTION WITH THE TUBING AT THAT POINT. THE DEVICE WAS 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 17160706 ↗
• MalfunctionJun 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, THE CUSTOMER REPORTED A LEAK SOMEWHERE AROUND THE LUER LOCK AS IT WAS NOT VERY CLEAR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER COULD NOT PINPOINT WHERE THE LEAK WAS COMING FROM. THE LUER LOCK WAS CLEAR. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE CUSTOMER STATED THAT THE PATIENT BLOODLOSS WAS APPROXIMATELY 200ML. A TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THE LEAK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17104895 ↗

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.