DLP® Aortic Root Cannula with Flow-Guard™ Introducer 21012Recalls & reported problems

Medtronic, Inc. · CANNULA 21012 AR VENT FLOW 12GA 20PK 17L · Class 2

All models of DLP Aortic Root Cannula with Flow-Guard Introducer (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613994495390), received between Aug 8, 2024 and Jan 6, 2025 — classified as 2 malfunctions.

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

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

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 18, 2026.

Reports received per month

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

Recalls naming this device

Feb 5, 2025Class IOpen, Classified
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
Z-1306-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

Material Separation2
Crack1
Material Deformation1

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.

MalfunctionJan 6, 2025Crack; Material Separation; Crack; Material Separation
IT WAS REPORTED THAT DURING THE PRE-OPERATIVE INSPECTION OF A DLP AORTIC ROOT CANNULA WITH A VENT LINE, THE PLASTIC RETAINING NODULES THAT HOLD THE INSERTION NEEDLE INSIDE THE CANNULA WERE FOUND BROKEN OFF INSIDE THE BLUE CONNECTOR. THERE WAS NO DAMAGE TO ANY PACKAGING AND NO VISIBLE DAMAGE TO OTHER PARTS OF THE CANNULA. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079264 ↗
MalfunctionAug 8, 2024Material Separation; Material Deformation; Material Separation; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA, IT WAS REPORTED THAT WHEN CANNULA WAS OPENED THE PLASTIC TIP WAS DAMAGED AND THE NEEDLE WAS LOOSE.THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937146 ↗

Device details

UDI-DI	`20613994495390`
Brand	DLP® Aortic Root Cannula with Flow-Guard™ Introducer
Model	21012
Company	Medtronic, Inc.
Product code	DWF · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Class	Class 2
FDA submission	K810548
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.

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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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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