Recall Z-1797-2024— Medtronic Perfusion Systems

Name: FDA recall Z-1797-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-19

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2024-03-19. It names one FDA 510(k) clearance: K850385. Product: Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP¿ Pericardial Sump 38.1 cm (15 in), Model Number 12010,. Reason: Potential for unsealed sterile packing..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2024-03-19
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K850385 — INTRACARDIAC SUMP 12010Dlp, Inc.·cleared 1985-04-29

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

Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP¿ Pericardial Sump 38.1 cm (15 in), Model Number 12010,

Reason for recall

Potential for unsealed sterile packing.

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