Medtronic Perfusion Systems: Medical Device Recall in 2021 - (Recall #: Z-0273-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Cardioblate CryoFlex Surgical Ablation Console

Product Classification:

Class II

Date Initiated: September 27, 2021

Date Posted: December 1, 2021

Recall Number: Z-0273-2022

Event ID: 88845

Reason for Recall:

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

Status: Ongoing

Product Quantity: 7 devices

Code Information:

1) Model 65CS1: Serial 10047 (GTIN 00763000014988) Serial 10048 (GTIN 00763000014988) Serial 10050 (GTIN 00763000014988) Serial 1689 (GTIN 00643169183834) Serial CSC-591 (GTIN 00613994867315) Serial CSC055 (GTIN 00613994867315) Serial 10051 (GTIN 00763000014988) 2) Model R65CS1: Serial RCSC-201 (GTIN 00613994981516)

Distribution Pattern:

Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea

Voluntary or Mandated:

Voluntary: Firm initiated