Medtronic Cardioblate CryoFlex Probe Recall: Defective Sterile Pouch Seals
Medtronic recalls Cardioblate CryoFlex surgical ablation probes with potential defective sterile pouch seals. This could lead to contamination during medical procedures. Affected models include 60SF7 with specific serial numbers.
Lower-risk recall
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Contact the company
What happened, in plain English
Medtronic is recalling Cardioblate CryoFlex surgical ablation probes due to a potential defect in the sterile barrier pouch seals. This could lead to contamination during medical procedures if the pouch fails to maintain sterility. Read more at govinfonow.com/recall/64097-medtronic-cardioblate-cryoflex-probe-recall-defective-sterile-pouch-seals.
Source Summary by GovInfoNow · govinfonow.com/recall/64097-medtronic-cardioblate-cryoflex-probe-recall-defective-sterile-pouch-seals · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0495-2021
Cite this page
“Medtronic Cardioblate CryoFlex Probe Recall: Defective Sterile Pouch Seals.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64097-medtronic-cardioblate-cryoflex-probe-recall-defective-sterile-pouch-seals. Based on FDA recall #Z-0495-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0495-2021%22&limit=1).
Why it’s dangerous
The sterile barrier pouch that packages the probe may have a defect in its seals. If the pouch fails to maintain sterility, it could lead to contamination during medical procedures. This poses a risk of infection or other complications for patients.
Who’s affected
Healthcare professionals using the Cardioblate CryoFlex probes for surgical ablation procedures are most at risk. Patients undergoing these procedures may be affected if the probe becomes contaminated.
How to tell if you have this one
Check for the model number 60SF7 on the probe. Look for serial numbers starting with 17720000 through 17720021 or 20620000. The product is a single-use disposable cryoprobe for surgical ablation.
- Brand
Medtronic- Product
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0493-2021 | 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.; 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 | 37 units |
| Z-0494-2021 | 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.; 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 | 57 units |
| Z-0495-2021 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 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.; Model Number 60SF7, GTIN 00763000114633, Serial Numbers: 17720000, 17720001, 17720002, 17720011, 17720012, 17720013, 17720014, 17720015, 17720016, 17720017, 17720018, 17720019, 17720020, 17720021, 20620000 | 15 units |
| Z-0496-2021 | 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.; Model Number 60CM1, GTIN 00763000114640, Serial Numbers: 18920000, 18920001, 18920002 | 3 units |
What to do — step by step
Check Product Details
Identify the model number (60SF7) and serial numbers (17720000-17720021 or 20620000) on the probe.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0495-2021 (October 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0495-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.