Recall Z-2482-2025— Medtronic Perfusion Systems

Name: FDA recall Z-2482-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-06

Class I · Ongoing

Class I FDA medical device recall by Medtronic Perfusion Systems, initiated 2025-08-06. It names one FDA 510(k) clearance: K834039. Product: DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115. Reason: The catheters may not retain their shape..

Recalling firm: Medtronic Perfusion Systems
Classification: Class I
Status: Ongoing
Initiated: 2025-08-06
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K834039 — INFANT VENT CATHETER 12001 W/SIDE VENTDlp, Inc.·cleared 1984-01-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.