Z-0273-2022Class II

Cardioblate CryoFlex Surgical Ablation Console

Name: Z-0273-2022 Cardioblate CryoFlex Surgical Ablation Console
Creator: Medtronic Perfusion Systems
Published: 2021-09-27
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2021-09-27 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Perfusion Systems began a recall of Cardioblate CryoFlex Surgical Ablation Console on 2021-09-27. FDA classified it as Class II and gives the reason as "There is potential for intermittent electrical connectivity between the console and probe". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0273-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-27
Posted: 2021-11-19
Recalling firm: Medtronic Perfusion Systems
Product: Cardioblate CryoFlex Surgical Ablation Console
Product code: OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Reason for recall: There is potential for intermittent electrical connectivity between the console and probe.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: In the United States (US), beginning 27-SEP-2021 Medtronic initiated communications of an Urgent Medical Device Correction letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records. Outside of the United States (OUS), beginning 27-SEP-2021, a written Urgent Medical Device Correction letter is being delivered via regionally approved methods to consignees who have received affected product according to Medtronic records. Consignees are asked to review the Medtronic Urgent Medical Device Correction notification and follow the Recommended Actions, including quarantining affected Cardioblate CryoFlex Surgical Ablation Consoles in their inventory for servicing.
Quantity in commerce: 7 devices
Distribution: Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0273-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0273-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-19

Product code OCL

K123733Class IICardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc. / cleared 2013-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)