Cardioblate® CryoFlex® 60CM1Recalls & reported problems
Medtronic, Inc. · CLAMP 60CM1 CRYOFLEX PROBE 26L · Class 2
All models of Cardioblate CryoFlex (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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
- 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-0496-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
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, ClassifiedCardioblate CryoFlex Surgical Ablation Console
- Z-0495-2021 · Oct 12, 2020 · TerminatedCardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex S
- Z-0493-2021 · Oct 12, 2020 · TerminatedCardioblate 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 · TerminatedCardioblate 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
Other Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue devices
- Cardioblate® CryoFlex® 60SF3Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall7 deaths41 reports
- Cardioblate® CryoFlex® 60SF2Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall13 reports
- Cardioblate® CryoFlex® 65CS1Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 death11 reports
- Cardioblate® CryoFlex® 65CS1Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 death6 reports
- CARDIOBLATE® GEMINI® 49260Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 report
- Cardioblate® CryoFlex® 60SF7Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 report
- Fusion Ablation System 001-700-002Atricure, Inc. · Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue1 recall0 reports
- Fusion Ablation System 001-700-001SAtricure, Inc. · Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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