DLP® 68128Recalls & reported problems

Medtronic, Inc. · CANNULA 68128 SS VEN MALL 28FR 10PK 17L · Class 2

All models of DLP (151)

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: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994879398), received between Mar 21, 2025 and Mar 21, 2025 — classified as 1 malfunction.

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

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

2 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. 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

Mar 19, 2024Class IIOpen, Classified
Potential for unsealed sterile packing.
Z-1805-2024 · Root cause: Process control · Recall details · FDA record ↗

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.

MalfunctionMar 21, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A SCHEDULED VALVE SPARING ROOT REPLACEMENT ((B)(6)) SURGERY FOR A PATIENT, DUE TO DILATION OF THE AORTIC ROOT AND ASCENDING AORTA, THE PERFUSION STAFF HANDED A 28 FR MALLEABLE VENOUS CANNULA TO THE SURGEON. UPON OPENING THE PRIMARY PACKAGING, THE SURGEON IDENTIFIED A DEFORMITY IN THE CANNULA, PROMPTING AN IMMEDIATE CHANGE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21661347 ↗

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-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,
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

Device details

UDI-DI	`20613994879398`
Brand	DLP®
Model	68128
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 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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