SMARTFREEZE™ M004CRBS400R0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729992721), received between Dec 11, 2023 and Mar 27, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 reports).

7 other recalls cover devices cleared under the same FDA submission (P220032); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2024Defective Device; Gas/Air Leak; Infusion or Flow Problem; Temperature Problem; Defective Device; Gas/Air Leak; Infusion or Flow Problem; Temperature Problem

  DURING A ATRIAL FIBRILLATION (A FIB) PROCEDURE A SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE. AFTER PERFORMING THREE SUCCESSFUL ABLATIONS ON THE LEFT SIDE, THEN TO THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) WITHIN THE FIRST FREEZE A LOW TEMPERATURE ERROR OCCURRED. THE TEMPERATURE REACHED -72 WITHIN 20 SECONDS. THE PHYSICIAN MUST HAVE BEEN TOO DEEP IN THE VEIN AND WAS NOT USING FLUORO AND GOING OFF OF WAVEFORMS. THE LOW TEMPERATURE ERROR WAS CLEARED AND NOW WAITING FOR BALLOON TO THAW. DURING THE THAWING PROCESS A REFRIGERANT FLOW OBSTRUCTION ERROR OCCURRED. TROUBLESHOOTING INCLUDES A COMBINATION OF TURNING OFF THE VACUUM, ROTATING THE CRYO CABLE 180 DEGREES, RECONNECTING THE CABLE, AND REINITIATING THE VACUUM. THE ERROR CODE COULD NOT BE CLEARED. ADDITIONAL TROUBLESHOOTING INCLUDES REPLACING THE CRYO CABLE AND REINITIATING THE VACUUM, STILL THE ERROR CODE PERSISTED. THEN A HARDWARE PROBLEM ERROR MESSAGE OCCURRED. DURING THIS TIME OF TROUBLESHOOTING, TECHNICAL SUPPORT WAS CALLED FOR ADDITIONAL ASSISTANCE. AFTER WAITING 5 MINUTES THE VACUUM WAS REINITIATED AGAIN AND THE HARDWARE ERROR PERSISTED. A NEW BALLOON AND CRYO CABLE WERE ALSO OPENED DURING THIS TIME AS A METHOD OF TROUBLESHOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987714 ↗
• MalfunctionDec 11, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING ONGOING USE THERE WAS A LEAK FROM THE CONSOLE. THE SITE CONTACTED TECH SERVICES TO NOTIFY THEM THAT THE SMARTFREEZE CONSOLE WAS LEAKING. THIS WAS NOT DURING A PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT, NO INJURY TO ANY OTHER PERSONAL WAS REPORTED. THE ISSUE COULD NOT BE TROUBLESHOOTED OVER THE PHONE SO A FIELD SERVICE ENGINEER WENT TO THE SITE. DAMAGE TO THE HOSE THAT RUNS BETWEEN THE N2O TANK AND THE PROCESSING PLATE WAS IDENTIFIED. REPLACEMENT OF THE HOSE WAS REQUIRED. THE CONSOLE IS NOT EXPECTED TO BE RETURNED AS IT WAS SERVICED ON SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301132 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P220032. One submission often covers many models, so check the product and lot details in each record.

• Z-0301-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
• Z-0303-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H
• Z-0298-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
• Z-0299-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
• Z-0297-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
• Z-0300-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
• Z-0302-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160