CLASS I ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report

Smartfreeze Cryo Console: Console: Material Number M004CRBS4000 recalled

Boston Scientific is recalling Boston Scientific Smartfreeze Cryo Console: Console: Material Number M004CRBS4000. The recall was initiated on 10 Oct 2024 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN 08714729992691
Quantity recalled1035 units

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-0303-2025
FDA event ID
95514
Recalling firm
Boston Scientific, Saint Paul, MN
Classification
Class I
Status
Ongoing
Recall initiated
10 Oct 2024
FDA classified
12 Nov 2024
Reported
20 Nov 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

10 Oct 2024Recall initiated by company
12 Nov 2024Classified by FDA+33 days
20 Nov 2024Published in enforcement report+8 days

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

Reason for recall

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Product as listed by the FDA

Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0

Where it was distributed

Worldwide

Questions about this recall

Is Smartfreeze Cryo Console: Console: Material Number M004CRBS4000 recalled?

Yes. Boston Scientific recalled Smartfreeze Cryo Console: Console: Material Number M004CRBS4000 on 10 Oct 2024. The recall is Class I and its status is Ongoing. Recall number Z-0303-2025.

Why was it recalled?

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Which lots are affected?

GTIN 08714729992691

Where was it sold?

Worldwide

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 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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