CLASS II ONGOING Device recall · Reported 1 Dec 2021 · FDA Enforcement Report

Cardioblate CryoFlex Surgical Ablation Console recalled

Medtronic Perfusion Systems is recalling Cardioblate CryoFlex Surgical Ablation Console, distributed in Illinois, Kansas, Utah. The recall was initiated on 27 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) Model 65CS1: Serial 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 R65CS1: Serial RCSC-201 (GTIN 00613994981516)

Quantity recalled7 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0273-2022
FDA event ID: 88845
Recalling firm: Medtronic Perfusion Systems, Brooklyn Park, MN
Classification: Class II
Status: Ongoing
Recall initiated: 27 Sep 2021
FDA classified: 19 Nov 2021
Reported: 1 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

27 Sep 2021	Recall initiated by company
19 Nov 2021	Classified by FDA	+53 days
1 Dec 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is potential for intermittent electrical connectivity between the console and probe.

Product as listed by the FDA

Cardioblate CryoFlex Surgical Ablation Console

Where it was distributed

Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea

Illinois Kansas Utah

Questions about this recall

Why was it recalled?

There is potential for intermittent electrical connectivity between the console and probe.

Which lots are affected?

1) Model 65CS1: Serial 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 R65CS1: Serial RCSC-201 (GTIN 00613994981516)

Where was it sold?

Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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