FDA recall Z-0493-2021

MEDTRONIC ATS MEDICAL, INC. · Class II · device

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 for recall

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

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.

Key facts

Status: Terminated
Initiation date: 2020-10-12
Report date: 2020-12-02
Termination date: 2024-08-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0493-2021