FDA Medical Device Recalls (openFDA)
MEDTRONIC ATS MEDICAL, INC.: 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.
- Recall number
- Z-0493-2021
- Recalling firm
- MEDTRONIC ATS MEDICAL, INC.
- 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.
- Status
- Terminated
- Initiated
- 2020-10-12
- Posted
- not on file
- Terminated
- 2024-08-16
- Reason
- There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- 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 RS.CFQFCA@medtronic.com. > - Please forward this notice to all those who need to be aware within your organization.
- Quantity
- 37 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.
- Lot, serial or model codes
- Model Number 60SF2, GTIN 00763000114619, Serial Numbers: 18920030, 18920031, 18920032, 18920033, 18920034, 18920035, 18920036, 18920037, 18920038, 18920039, 18920040, 18920041, 18920043, 18920045, 18920046, 18920047, 18920048, 18920049, 18920050, 18920051, 18920052, 18920053, 18920054, 18920055, 20420030, 20420031, 20420032, 20420033, 20420038, 20420039, 20420040, 20420041, 20420046, 20420047, 20420049, 20420050, 20420051
- 510(k) numbers
- K123733
- PMA numbers
- not on file
- Product code
- OCL
- Firm FEI
- 3008592544
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28