DLP® 68112Recalls & reported problems

Medtronic, Inc. · CANNULA 68112 SS VEN MALL 12FR 10PK 17L · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 20613994879473), received between Dec 6, 2024 and Dec 6, 2024 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K022272); 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.

Reports received per month

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

Most reported problems

Device problems

Material Deformation1
Obstruction of Flow1

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.

MalfunctionDec 6, 2024Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation
IT WAS REPORTED THAT PRIOR TO USE OF A DLP MALLEABLE SINGLE STAGE VENOUS CANNULA IT WAS FOUND TO BE DAMAGED/DEFORMED WITH INDENTATIONS IN THE BODY. THE LOCATION OF THE DAMAGE WAS SPECIFIED, AND IT WAS NOTED THAT THESE DENTS MIGHT HAVE IMPEDED BLOOD FLOW IF THE DEVICE HAD BEEN USED. THE PACKAGING WAS NOT DAMAGED, AND NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE AFFECTED. THE DEVICE WAS NOT USED, AND IT WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20862081 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022272. One submission often covers many models, so check the product and lot details in each record.

Z-1805-2024 · Mar 19, 2024 · Open, Classified
Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c)
Z-0810-2012 · Dec 14, 2011 · Terminated
Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model #'s 68112, 68114, 68116, 68118, 68120, 68122, 68124, 68
Z-0812-2012 · Dec 14, 2011 · Terminated
Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic. Model # 's CB66112, CB66114, CB66116,

Device details

UDI-DI	`20613994879473`
Brand	DLP®
Model	68112
Company	Medtronic, Inc.
Product code	DWF · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Class	Class 2
FDA submission	K022272
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 19, 2024

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

A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as a venous cannula. It is typically inserted using a compatible trocar blade which may be included. 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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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