DLP® 12218Recalls & reported problems

Medtronic, Inc. · CANNULA 12218 AR 18GA BLUE TIP 20PK 17L · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994540106), received between Apr 19, 2024 and Apr 19, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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.

Reports received per month

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

Most reported problems

Device problems

Material Deformation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 19, 2024Material Deformation; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS HAD DLP AORTIC ROOT CANNULA HAD A CONNECTOR THAT WAS TOO WEAK AND LEAKY. THE CUSTOMER STATED THAT AIR IS PUMPED THROUGH THE CONNECTION. THE USE OF THE DEVICE IS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19141541 ↗

Device details

UDI-DI	`20613994540106`
Brand	DLP®
Model	12218
Company	Medtronic, Inc.
Product code	DWF · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Class	Class 2
FDA submission	K040173
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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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.