Recall Z-2505-2021— Medtronic Perfusion Systems

Name: FDA recall Z-2505-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-24

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2021-08-24. It names one FDA 510(k) clearance: K834352. Product: DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only. Reason: Potential for a wire protrusion through the left heart vent catheter tip.

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2021-08-24
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K834352 — ADULT VENT CATHETERDlp, Inc.·cleared 1984-01-27

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 Catheters, 18 FR. Sterile, Rx Only

Reason for recall

Potential for a wire protrusion through the left heart vent catheter tip

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