DLP™ 77010 (UDI 20763000091112)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20763000091112), received between Aug 31, 2023 and Jun 2, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Misassembled During Installation” (5 reports).

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

2 other recalls 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. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1793-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, DUST AND PARTICLES WERE FOUND INSIDE THE STERILE PACKAGE AND ONE OF THE CANNULAE HAD LOOSE CAPS. THE DEVICES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360877 ↗
• MalfunctionMay 23, 2025Contamination; Misassembled During Installation; Contamination; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, IT WAS REPORTED THAT THERE WAS DIRT IN THE POUCHES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STERILE BARRIERS WERE STILL SEALED WHEN THE FOREIGN MATERIAL (FM) WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077230 ↗
• MalfunctionMay 23, 2025Contamination; Misassembled During Installation; Contamination; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, IT WAS REPORTED THAT THERE WAS DIRT IN THE POUCHES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STERILE BARRIERS WERE STILL SEALED WHEN THE FOREIGN MATERIAL (FM) WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077192 ↗
• MalfunctionMay 23, 2025Contamination; Misassembled During Installation; Contamination; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, IT WAS REPORTED THAT THERE WAS DIRT IN THE POUCHES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STERILE BARRIERS WERE STILL SEALED WHEN THE FOREIGN MATERIAL (FM) WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077146 ↗
• MalfunctionOct 8, 2024Mechanical Problem; Misassembled During Installation; Mechanical Problem; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THE CUSTOMER FOUND THAT THE TUBE CORE AND THE CANNULA BODY DID NOT MATCH AFTER UNPACKING. THE TUBE CORE WAS TOO SHORT FOR THE TIP TO COME OUT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20395362 ↗
• MalfunctionAug 28, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THE TIP OF THE CANNULA COULD NOT BE PULLED. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP OF THE CANNULA COULD NOT BE PULLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20083385 ↗
• MalfunctionAug 23, 2024Obstruction of Flow; Misassembled During Installation; Obstruction of Flow; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA HAD A CAP OF THE INTRODUCER THAT WAS FITTED BACKWARDS; HENCE, IT DOES NOT OCCLUDE THE CANNULA. NO PATIENT WAS HURT, AS THE DEFECT WAS NOTICED TIMELY. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20046007 ↗
• MalfunctionJun 18, 2024Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THE CUSTOMER OBSERVED THAT THE DEVICE ACCESSORIES HAD FALLEN OFF WHEN THE HOSPITAL WAS CHECKING THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICES WERE DAMAGED, THE INNER CORE FRACTURES HAD FALLEN OFF ON EACH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557163 ↗
• MalfunctionNov 28, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA IT WAS NOTED THAT THE CANNULA HAD A TEAR. THE TEAR WAS NOTICED WHEN THE LIVER FROM THE PUMP HAD BEEN REMOVED. THE DEVICE WAS REPLACED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215145 ↗
• MalfunctionAug 31, 2023Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, THE CUSTOMER REPORTED A CUT IN THE FRONT OF THE CANNULA WHICH WAS OBSERVED AFTER STARTING BYPASS. SEE ATTACHED PHOTOS. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.  THE CANNULA WAS POSSIBLY TIED TOO TIGHT BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660934 ↗

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-2738-2026 · May 25, 2026 · Open, Classified
  Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
• Z-0984-2025 · Dec 12, 2024 · Open, Classified
  DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)