DLP® 10012Recalls & reported problems

Medtronic, Inc. · CANNULA 10012 AORTIC ROOT 12GA 20PK 17L · Class 2

All models of DLP (151)

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613994540250), received between Apr 30, 2024 and Jul 15, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K790565); 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

Material Deformation2
Mechanical Problem2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

MalfunctionJul 15, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA, IT WAS REPORTED THAT AS THE CUSTOMER WAS CANNULATING, THE CUSTOMER COULD NOT TWIST THE TOP OFF THE DEVICE. WHEN THE TOP EVENTUALLY TWISTED OFF, THE INNER PLASTIC SLEEVE BROKE OFF INSIDE THE SHEATH SO THAT THE NEEDLE COULD NOT BE REMOVED. 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 19738473 ↗
MalfunctionApr 30, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA, THE CUSTOMER REPORTED THAT THE DEVICE WAS DAMAGED/DEFORMED. THE BLUE PIECE INTERNALLY BROKE OFF AND THE CUSTOMER WAS UNABLE TO REMOVE NEEDLE DUE TO BROKEN LUER AND BLUE PIECE INSIDE. THE CUSTOMER ALSO REPORTED THAT THE TOP LUER CONNECTION WAS NOT WORKING. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19211618 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K790565. One submission often covers many models, so check the product and lot details in each record.

Z-0289-2025 · Oct 3, 2024 · Open, Classified
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

Device details

UDI-DI	`20613994540250`
Brand	DLP®
Model	10012
Company	Medtronic, Inc.
Product code	DWF · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Class	Class 2
FDA submission	K790565
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 6, 2018

Device type (GMDN): Cardioplegia cannula

A sterile, single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device.

Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices

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DLP™ 77008
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NA HY11W65R1
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DLP® 12113
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DLP® Aortic Root Cannula with Flow-Guard™ 11012
Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
2 recalls5 reports
EOPA™ 77622
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2 recalls4 reports
NA HY11R00R6
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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.

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