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Medtronic Perfusion DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 - safety alert

Official notice

10 Sept 2025

Last checked

10 Sept 2025

Critical riskFDA

An official FDA notice concerns Medtronic Perfusion DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 - safety alert. An official FDA notice concerns DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-09-10. Recall numbers: Z-2480-2025. Check the official notice for the complete list. Published 2025-09-10.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

34,549

Recall number

Z-2480-2025

Official notice

2025-09-10

The hazard

An official FDA notice concerns DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-09-10. Recall numbers: Z-2480-2025. Check the official notice for the complete list.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

UDI-DI 20643169881338

Event Ids

97295

Recall Numbers

Z-2480-2025

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Affected products

Product 1

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113

Units affected

34,549

Risk / hazard

An official FDA notice concerns DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-09-10. Recall numbers: Z-2480-2025. Check the official notice for the complete list.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States · MN · Brooklyn Park

Affected area 1

US · United States · MN · Brooklyn Park

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic Perfusion. Contact: Medtronic Perfusion Systems.

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

critical

Recall details

Recall number

Z-2480-2025

Event id

97295

Units affected

34,549

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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