Recall Z-0493-2021— MEDTRONIC ATS MEDICAL, INC.

Name: FDA recall Z-0493-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-12

Class II · Terminated

Class II FDA medical device recall by MEDTRONIC ATS MEDICAL, INC., initiated 2020-10-12, terminated 2024-08-16. It names one FDA 510(k) clearance: K123733. Product: Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.. Reason: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices.

Recalling firm: MEDTRONIC ATS MEDICAL, INC.
Classification: Class II
Status: Terminated
Initiated: 2020-10-12
Terminated: 2024-08-16
Firm location: Plymouth, 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 Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

Reason for recall

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

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