DLP® 62000Recalls & reported problems

Medtronic, Inc. · SET 62000 PRESSURE DISPLAY 45 10PK 17L · Class 2

All models of DLP (151)

Data updated Oct 16, 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: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

3 other recalls cover devices cleared under the same FDA submission (K852232); 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 16, 2026.

Recalls naming this device

Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1802-2024 · Root cause: Process control · Recall details · FDA record ↗
Jun 22, 2017Terminated
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Z-2768-2017 · Root cause: Packaging process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K852232. One submission often covers many models, so check the product and lot details in each record.

Z-0077-2012 · Sep 9, 2011 · Terminated
Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring pressure between -100 mmHg and +500 mmHg with an accuracy of +/-5 mmHg from -100 mmHg
Z-0078-2012 · Sep 9, 2011 · Terminated
Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acryl
Z-0079-2012 · Sep 9, 2011 · Terminated
Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyro

Device details

UDI-DI	`20613994846642`
Brand	DLP®
Model	62000
Company	Medtronic, Inc.
Product code	DXS · GAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS
Class	Class 2
FDA submission	K852232
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): Patient monitoring system module, blood pressure, invasive

A small unit dedicated to the measurement of invasive blood pressure (from one or more sites) obtained through a pressure transducer introduced directly into a blood vessel via a catheter. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.

Other GAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS devices

DLP® 61000
Medtronic, Inc. · GAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS
1 recall0 reports

All GAUGE, PRESSURE, CORONARY, 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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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