PlainRecalls
FDA Devices Critical Class I Ongoing

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

Reported: September 10, 2025 Initiated: August 6, 2025 #Z-2482-2025

Product Description

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

Reason for Recall

The catheters may not retain their shape.

Details

Units Affected
25261 units
Distribution
Worldwide - US Nationwide distribution.
Location
Brooklyn Park, MN

Frequently Asked Questions

What product was recalled?
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115. Recalled by Medtronic Perfusion Systems. Units affected: 25261 units.
Why was this product recalled?
The catheters may not retain their shape.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 10, 2025. Severity: Critical. Recall number: Z-2482-2025.