Z-0494-2021Class II

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a...

Name: Z-0494-2021 Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a...
Creator: Medtronic Ats Medical, Inc.
Published: 2020-10-12
License: https://open.fda.gov/license/

Medtronic, Inc. (Minneapolis, MN 55447) / initiated 2020-10-12 / Terminated / root cause: packaging

FDA source

MEDTRONIC ATS MEDICAL, INC. began a recall of Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for... on 2020-10-12. FDA classified it as Class II and gives the reason as "There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0494-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-12
Posted: 2020-11-25
Terminated: 2024-08-16
Recalling firm: Medtronic, Inc. (Minneapolis, MN 55447)
Product: Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 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.
Product code: OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Reason for recall: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: In the United States (US), beginning 29-Oct-2020, a written Medical Device Correction letter will be mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification. The letter requests the following actions: - Identify and quarantine all unused CryoFlex Surgical Ablation devices as listed in the table below. - Return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-854-3570 to initiate a product return. Your local Medtronic Representative can assist you in the return of this product. - < Please complete the enclosed Customer Confirmation Form and email to [email protected]. > - Please forward this notice to all those who need to be aware within your organization.
Quantity in commerce: 57 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.
Product codes and lots: Model Number 60SF3, GTIN 00763000114626 Serial Numbers: 17420000, 17420001, 17420002, 17420003, 17420004, 17420005, 17420006, 17420007, 17420008, 17420009, 17420010, 17420013, 17420014, 17420015, 17420016, 17420017, 17420018, 17420019, 17420020, 17420022, 17420023, 17420024, 17420025, 17420026, 17420027, 17420028, 17420029, 18420000, 18420001, 18420002, 18420003, 18420004, 18420015, 18420016, 18420021, 18420022, 18420023, 18420024, 18420025, 18420026, 18420027, 19820016, 19820017, 19820018, 19820019, 19820020, 19820021, 19820022, 19820023, 19820024, 21020005, 22320038, 22320040, 22320041, 22320042, 22320043, 22320044

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0494-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0493-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-25
Z-0494-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-25
Z-0495-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-25
Z-0496-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-25

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)