DLP® 94725Recalls & reported problems

Medtronic, Inc. · CANNULA 94725 RCSP 15FR SIL-MAN 10P 17L · Class 2

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 20643169454730), received between May 9, 2024 and May 9, 2024 — 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.

8 other recalls cover devices cleared under the same FDA submission (K860149); 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.

Recalls naming this device

Apr 21, 2026Open, Classified
Certain lots of product have the potential for a sterile barrier breach.
Z-2218-2026 · Root cause: Packaging process control · 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.

MalfunctionMay 9, 2024Material Deformation; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP SILICONE RCSP CANNULA WITH MANUAL-INFLATE CUFF HAD A PIN HOLE IN THE BALLOON. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19275731 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K860149. One submission often covers many models, so check the product and lot details in each record.

Z-2214-2026 · Apr 21, 2026 · Open, Classified
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Z-2219-2026 · Apr 21, 2026 · Open, Classified
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Z-2220-2026 · Apr 21, 2026 · Open, Classified
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
Z-2216-2026 · Apr 21, 2026 · Open, Classified
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Z-2221-2026 · Apr 21, 2026 · Open, Classified
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Z-2217-2026 · Apr 21, 2026 · Open, Classified
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Z-2222-2026 · Apr 21, 2026 · Open, Classified
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Z-2215-2026 · Apr 21, 2026 · Open, Classified
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter

Device details

UDI-DI	`20643169454730`
Brand	DLP®
Model	94725
Company	Medtronic, Inc.
Product code	DWF · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Class	Class 2
FDA submission	K860149
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): Coronary sinus cannula

A sterile, rigid or semi-rigid tube designed to be surgically inserted, temporarily, into the ostium of the coronary sinus to provide retrograde coronary perfusion/cardioplegia during cardiopulmonary bypass or minimally invasive surgery. It may be equipped with a self-inflating low pressure balloon that is typically used for back flushing the coronary vessel in the event of inadvertent coronary air embolization. Insertion is achieved with the use of a removable stylet or trocar. 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.