SMARTFREEZE™ M004CRBS400Z0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729997481), received between Sep 24, 2024 and Sep 24, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Infusion or Flow Problem; Infusion or Flow Problem

  DURING A MEDICAL EVENT, A SMARTFREEZE DEVICE WAS CHOSEN FOR OPERATION. AN ERROR WAS REPORTED, SPECIFICALLY AN RFO, INDICATING A REFRIGERANT FLOW OBSTRUCTION DETECTED. THIS INCIDENT TOOK PLACE EXTERNAL TO THE PATIENT. THERE IS NO INFORMATION AVAILABLE REGARDING THE DEVICE'S RETURN. CONSEQUENTLY, THE PROCEDURE WAS TERMINATED. IT REMAINS UNCLEAR WHETHER THE PATIENT WAS UNDER SEDATION WHEN THE ISSUE AROSE. IT IS UNKNOWN IF THE DEVICE WILL BE AVAILABLE FOR RETURN. DURING A FIELD SERVICE VISIT, THE CRYO-CONNECTOR, MICRON FILTER, AND CHECK VALVE SUB-ASSEMBLY (CV6) WERE REPLACED; HOWEVER, THE RFO ERROR PERSISTED. FURTHER INSPECTION REVEALED A LEAK IN THE CRBS SOLENOID VALVE ASSEMBLY SV1. IN THE SECOND SERVICE INTERVENTION, BOTH SV1 AND THE CRBS SOLENOID VALVE ASSEMBLY SV9 WERE REPLACED. HOWEVER, THE ABLATION TEST FAILED DUE TO AN OUTER BALLOON PRESSURE ERROR. A THIRD REPLACEMENT WAS CONDUCTED, WHICH INCLUDED THE CRBS CRYO-CONNECTOR WITH TYGON TUBING ASSEMBLY AND THE CRBS SV9 EXTENSION TUBING ASSEMBLY. THIS FINAL INTERVENTION SUCCESSFULLY RESOLVED BOTH THE FUNCTIONAL AND ABLATION TEST ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292424 ↗

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-0297-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
• 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-0301-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
• Z-0302-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
• Z-0299-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
• Z-0300-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
• Z-0298-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100