Medtronic Cardioblate CryoFlex Console: Intermittent Electrical Connectivity Risk
Medtronic recalls Cardioblate CryoFlex Surgical Ablation Consoles with potential intermittent electrical connectivity between console and probe. Affected units have specific serial numbers and models.
Lower-risk recall
There is potential for intermittent electrical connectivity between the console and probe.
Contact the company
What happened, in plain English
Medtronic is recalling Cardioblate CryoFlex Surgical Ablation Consoles that may have intermittent electrical connectivity between the console and probe. This could lead to improper function during surgery, but the recall does not specify a risk of injury or serious harm. Read more at govinfonow.com/recall/61751-medtronic-cardioblate-cryoflex-console-intermittent-electrical-connectivity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61751-medtronic-cardioblate-cryoflex-console-intermittent-electrical-connectivity-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0273-2022
Cite this page
“Medtronic Cardioblate CryoFlex Console: Intermittent Electrical Connectivity Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61751-medtronic-cardioblate-cryoflex-console-intermittent-electrical-connectivity-risk. Based on FDA recall #Z-0273-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0273-2022%22&limit=1).
Why it’s dangerous
The console may have intermittent electrical connectivity with the probe, which could cause improper function during surgery. However, the recall does not indicate a risk of injury or serious harm.
Who’s affected
Surgical teams using the Cardioblate CryoFlex Console for procedures. The risk is low as the hazard does not involve immediate injury or serious harm.
How to tell if you have this one
Check for specific serial numbers: 10047, 10048, 10050, 1689, CSC-591, CSC055, 10051 for Model 65CS1; RCSC-201 for Model R65CS1. These units were sold with the listed GTINs.
- Brand
Medtronic Perfusion Systems- Product
Cardioblate CryoFlex Surgical Ablation Console- Category
Medical device
What to do — step by step
Check Serial Numbers
Identify if your console has the specific serial numbers listed: 10047, 10048, 10050, 1689, CSC-591, CSC055, 10051 for Model 65CS1 or RCSC-201 for Model R65CS1.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
FDA distribution: “Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Kansas, Utah.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0273-2022 (September 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0273-2022 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.