Recall Z-0273-2022— Medtronic Perfusion Systems

Name: FDA recall Z-0273-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-27

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2021-09-27. It names one FDA 510(k) clearance: K123733. Product: Cardioblate CryoFlex Surgical Ablation Console. Reason: There is potential for intermittent electrical connectivity between the console and probe..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2021-09-27
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K123733 — CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEMMedtronic, Inc.·cleared 2013-04-01

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

Cardioblate CryoFlex Surgical Ablation Console

Reason for recall

There is potential for intermittent electrical connectivity between the console and probe.

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