Reported Dec 1, 2021 · Ongoing
Cardioblate CryoFlex Surgical Ablation Console
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
- Cardioblate CryoFlex Surgical Ablation Console
- Lot codes and dates
- 1)
- Model 65CS1Serial 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 R65CS1Serial RCSC-201 (GTIN 00613994981516)
- Amount recalled
- 7 devices
Where it was sold
Why it was recalled
There is potential for intermittent electrical connectivity between the console and probe.
This product could cause temporary or reversible health problems — stop using it.
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