Cardioblate® CryoFlex® 60SF7Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000114633), received between Jul 15, 2025 and Jul 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K123733); 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 18, 2026.

Recalls naming this device

1. Oct 12, 2020Class IITerminated

   There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

   Z-0495-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionJul 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING MANUAL BENDING PRIOR TO USE, THE COILED WIRE OF THE CRYOFLEX PROBE BECAME DAMAGED AND DETACHED WHILE SHAPING THE TIP OF THE DEVICE TO MATCH THE LESION. THE ISSUE WAS IDENTIFIED IMMEDIATELY AS A DEVICE DEFECT BEFORE PATIENT USE, AND THE PRODUCT WAS REMOVED FROM THE STERILE FIELD. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505452 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123733. One submission often covers many models, so check the product and lot details in each record.

• Z-0273-2022 · Sep 27, 2021 · Open, Classified
  Cardioblate CryoFlex Surgical Ablation Console
• Z-0493-2021 · Oct 12, 2020 · Terminated
  Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use wit
• Z-0494-2021 · Oct 12, 2020 · Terminated
  Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex
• Z-0496-2021 · Oct 12, 2020 · Terminated
  Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex