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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

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