FDA recall Z-0496-2021

Product

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - 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-0496-2021