DLP™ 77010 (UDI 20763000946689)Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 20763000946689), received between Feb 18, 2025 and Feb 9, 2026 — classified as 154 malfunctions.

The most frequently reported specific device problem is “Material Separation” (152 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K024069); 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.

Recalls naming this device

1. May 25, 2026Open, Classified

   Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

   Z-2738-2026 · Root cause: Packaging · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Material Separation

  IT WAS REPORTED THAT DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE WERE FOUND WITH DIRT INSIDE THE POUCH AND TWO CANNULAE HAD LOOSE CAPS INSIDE THE POUCH PRIOR TO USE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE FOREIGN MATERIAL (FM) WAS LOCATED INSIDE THE POUCHES. THE STERILE BARRIERS WERE STILL SEALED WHEN FM WAS IDENTIFIED. THE CAP WAS NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291518 ↗
• MalfunctionFeb 9, 2026Material Separation

  IT WAS REPORTED THAT DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE WERE FOUND WITH DIRT INSIDE THE POUCH AND TWO CANNULAE HAD LOOSE CAPS INSIDE THE POUCH PRIOR TO USE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE FOREIGN MATERIAL (FM) WAS LOCATED INSIDE THE POUCHES. THE STERILE BARRIERS WERE STILL SEALED WHEN FM WAS IDENTIFIED. THE CAP WAS NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291393 ↗
• MalfunctionJan 14, 2026Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF FIVE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, IT WAS REPORTED THAT ONE DEVICE HAD A LOOSE CAP AND FOUR DEVICES HAD DIRT INSIDE. THE USE OF THE DEVICES WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION, FROM ANALYSIS OF THE RETURNED DEVICE, THAT ONE ADDITIONAL CANNULA HAD A LOOSE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067272 ↗
• MalfunctionDec 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE, THESE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE WERE OBSERVED TO HAVE LOOSE WHITE CAPS. THE PACKAGING OR POUCHES WERE NOT DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742897 ↗
• MalfunctionDec 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE, THESE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE WERE OBSERVED TO HAVE LOOSE WHITE CAPS. THE PACKAGING OR POUCHES WERE NOT DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742634 ↗
• MalfunctionNov 17, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD HAD A LOOSE CAP ISSUE AND DIRT'S WERE FOUND INSIDE THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT,SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569924 ↗
• MalfunctionNov 17, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD HAD A LOOSE CAP ISSUE AND DIRT'S WERE FOUND INSIDE THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT,SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569812 ↗
• MalfunctionNov 17, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD HAD A LOOSE CAP ISSUE AND DIRT'S WERE FOUND INSIDE THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT,SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569740 ↗
• MalfunctionNov 17, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD A LOOSE CAP ISSUE AND DIRT'S WERE FOUND INSIDE THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569677 ↗
• MalfunctionNov 17, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD HAD A LOOSE CAP ISSUE AND DIRT'S WERE FOUND INSIDE THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT,SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569553 ↗
• MalfunctionNov 17, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD HAD A LOOSE CAP ISSUE AND DIRT'S WERE FOUND INSIDE THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT,SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569500 ↗
• MalfunctionNov 17, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD HAD A LOOSE CAP ISSUE AND DIRT'S WERE FOUND INSIDE THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569369 ↗
• MalfunctionNov 17, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD HAD A LOOSE CAP ISSUE AND DIRT'S WERE FOUND INSIDE THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569200 ↗
• MalfunctionNov 17, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD HAD A LOOSE CAP ISSUE AND DIRT'S WERE FOUND INSIDE THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT,SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569148 ↗
• MalfunctionNov 17, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD HAD A LOOSE CAP ISSUE AND DIRT'S WERE FOUND INSIDE THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT,SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569104 ↗
• MalfunctionNov 17, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD HAD A LOOSE CAP ISSUE AND DIRT'S WERE FOUND INSIDE THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT,SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568999 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD 2X LOOSE CAP AND 1X DIRT INSIDE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567845 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD 2X LOOSE CAP AND 1X DIRT INSIDE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567799 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THESE DEVICE'S HAD 1X LOOSE CAP AND 4X DIRT INSIDE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567775 ↗
• MalfunctionSep 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A LOOSE WHITE CAP WAS IDENTIFIED ON THESE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE PRIOR TO USE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074169 ↗
• MalfunctionSep 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A LOOSE WHITE CAP WAS IDENTIFIED ON THESE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE PRIOR TO USE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073943 ↗
• MalfunctionSep 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A LOOSE WHITE CAP WAS IDENTIFIED ON THESE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE PRIOR TO USE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073762 ↗
• MalfunctionSep 10, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, IT WAS REPORTED THAT THERE WAS DIRT OR A LOOSE CAP INSIDE THE POUCHES .THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015631 ↗
• MalfunctionSep 10, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, IT WAS REPORTED THAT THERE WAS DIRT OR A LOOSE CAP INSIDE THE POUCHES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015566 ↗
• MalfunctionSep 10, 2025Contamination; Material Separation; Contamination; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, IT WAS REPORTED THAT THERE WAS DIRT OR A LOOSE CAP INSIDE THE POUCHES .THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015513 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K024069. One submission often covers many models, so check the product and lot details in each record.

• Z-0984-2025 · Dec 12, 2024 · Open, Classified
  DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)