DLP™ 77208 (UDI 20763000946733)Recalls & reported problems

Medtronic, Inc. · CANNULA 77208 ART ONE PIECE 8FR 5PK 17L · Class 2

All models of DLP (151)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 7
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20763000946733), received between Feb 26, 2025 and Feb 26, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (7 reports).

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

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Markings/Labelling Problem7
Misassembled During Installation7

Patient problems

No Clinical Signs, Symptoms or Conditions7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 26, 2025Device Markings/Labelling Problem; Misassembled During Installation; Device Markings/Labelling Problem; Misassembled During Installation
IT WAS REPORTED THAT PRIOR TO USE OF DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, THE CANNULAE CAPS WERE SEPARATED UPON ARRIVAL. IT WAS QUERIED WHETHER IT WAS SAFE TO USE IT IN THIS CONDITION. THE BARCODE OF THE NEWLY ARRIVED PRODUCT ALSO SEEMED TO BE FOUR DIGITS LONGER THAN THE PREVIOUS ONE. THE PRODUCTS WERE DETERMINED TO BE UNUSABLE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS OBSERVED, WHEN THE CUSTOMER INSPECTED THE GOODS AFTER RECEIVING THEM. THERE WAS NO DAMAGED OBSERVED TO THE CAPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470956 ↗
MalfunctionFeb 26, 2025Device Markings/Labelling Problem; Misassembled During Installation; Device Markings/Labelling Problem; Misassembled During Installation
IT WAS REPORTED THAT PRIOR TO USE OF DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, THE CANNULAE CAPS WERE SEPARATED UPON ARRIVAL. IT WAS QUERIED WHETHER IT WAS SAFE TO USE IT IN THIS CONDITION. THE BARCODE OF THE NEWLY ARRIVED PRODUCT ALSO SEEMED TO BE FOUR DIGITS LONGER THAN THE PREVIOUS ONE. THE PRODUCTS WERE DETERMINED TO BE UNUSABLE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS OBSERVED, WHEN THE CUSTOMER INSPECTED THE GOODS AFTER RECEIVING THEM. THERE WAS NO DAMAGED OBSERVED TO THE CAPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470934 ↗
MalfunctionFeb 26, 2025Device Markings/Labelling Problem; Misassembled During Installation; Device Markings/Labelling Problem; Misassembled During Installation
IT WAS REPORTED THAT PRIOR TO USE OF DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, THE CANNULAE CAPS WERE SEPARATED UPON ARRIVAL. IT WAS QUERIED WHETHER IT WAS SAFE TO USE IT IN THIS CONDITION. THE BARCODE OF THE NEWLY ARRIVED PRODUCT ALSO SEEMED TO BE FOUR DIGITS LONGER THAN THE PREVIOUS ONE. THE PRODUCTS WERE DETERMINED TO BE UNUSABLE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS OBSERVED, WHEN THE CUSTOMER INSPECTED THE GOODS AFTER RECEIVING THEM. THERE WAS NO DAMAGED OBSERVED TO THE CAPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470898 ↗
MalfunctionFeb 26, 2025Device Markings/Labelling Problem; Misassembled During Installation; Device Markings/Labelling Problem; Misassembled During Installation
IT WAS REPORTED THAT PRIOR TO USE OF DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, THE CANNULAE CAPS WERE SEPARATED UPON ARRIVAL. IT WAS QUERIED WHETHER IT WAS SAFE TO USE IT IN THIS CONDITION. THE BARCODE OF THE NEWLY ARRIVED PRODUCT ALSO SEEMED TO BE FOUR DIGITS LONGER THAN THE PREVIOUS ONE. THE PRODUCTS WERE DETERMINED TO BE UNUSABLE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS OBSERVED, WHEN THE CUSTOMER INSPECTED THE GOODS AFTER RECEIVING THEM. THERE WAS NO DAMAGED OBSERVED TO THE CAPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470775 ↗
MalfunctionFeb 26, 2025Device Markings/Labelling Problem; Misassembled During Installation; Device Markings/Labelling Problem; Misassembled During Installation
IT WAS REPORTED THAT PRIOR TO USE OF DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, THE CANNULAE CAPS WERE SEPARATED UPON ARRIVAL. IT WAS QUERIED WHETHER IT WAS SAFE TO USE IT IN THIS CONDITION. THE BARCODE OF THE NEWLY ARRIVED PRODUCT ALSO SEEMED TO BE FOUR DIGITS LONGER THAN THE PREVIOUS ONE. THE PRODUCTS WERE DETERMINED TO BE UNUSABLE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS OBSERVED, WHEN THE CUSTOMER INSPECTED THE GOODS AFTER RECEIVING THEM. THERE WAS NO DAMAGED OBSERVED TO THE CAPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470738 ↗
MalfunctionFeb 26, 2025Device Markings/Labelling Problem; Misassembled During Installation; Device Markings/Labelling Problem; Misassembled During Installation
IT WAS REPORTED THAT PRIOR TO USE OF DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, THE CANNULAE CAPS WERE SEPARATED UPON ARRIVAL. IT WAS QUERIED WHETHER IT WAS SAFE TO USE IT IN THIS CONDITION. THE BARCODE OF THE NEWLY ARRIVED PRODUCT ALSO SEEMED TO BE FOUR DIGITS LONGER THAN THE PREVIOUS ONE. THE PRODUCTS WERE DETERMINED TO BE UNUSABLE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS OBSERVED, WHEN THE CUSTOMER INSPECTED THE GOODS AFTER RECEIVING THEM. THERE WAS NO DAMAGED OBSERVED TO THE CAPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470719 ↗
MalfunctionFeb 26, 2025Device Markings/Labelling Problem; Misassembled During Installation; Device Markings/Labelling Problem; Misassembled During Installation
IT WAS REPORTED THAT PRIOR TO USE OF DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, THE CANNULAE CAPS WERE SEPARATED UPON ARRIVAL. IT WAS QUERIED WHETHER IT WAS SAFE TO USE IT IN THIS CONDITION. THE BARCODE OF THE NEWLY ARRIVED PRODUCT ALSO SEEMED TO BE FOUR DIGITS LONGER THAN THE PREVIOUS ONE. THE PRODUCTS WERE DETERMINED TO BE UNUSABLE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS OBSERVED, WHEN THE CUSTOMER INSPECTED THE GOODS AFTER RECEIVING THEM. THERE WAS NO DAMAGED OBSERVED TO THE CAPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470695 ↗

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)

Device details

UDI-DI	`20763000946733`
Brand	DLP™
Model	77208
Company	Medtronic, Inc.
Product code	DWF · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Class	Class 2
FDA submission	K024069
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 26, 2024

Device type (GMDN): Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

A semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.

Other Catheter, cannula and tubing, vascular, cardiopulmonary bypass devices

DLP™ 77010
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
1 recall154 reports
EOPA™ 77422
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls19 reports
DLP™ 77008
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls9 reports
NA HY11W65R1
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls8 reports
DLP® 12113
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls6 reports
DLP® Aortic Root Cannula with Flow-Guard™ 11012
Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
2 recalls5 reports
EOPA™ 77622
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls4 reports
NA HY11R00R6
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls3 reports

All Catheter, cannula and tubing, vascular, cardiopulmonary bypass devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page