Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
FDA adverse event reports and recall history for surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue (product code OCL), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 760
- Deaths
- 86
- Injuries
- 453
- Malfunctions
- 215
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-03-06TerminatedEmployee error
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
- 2010-09-27TerminatedDevice Design
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.
- 2010-09-27TerminatedDevice Design
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.
- 2010-06-07TerminatedOther
St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablation System. St. Jude Medical 240 Santa Ana Court, Sunnyvale, CA 94085 USA
The firm states that overheating of cardiac tissue is caused by inadequate cooling. The potential exists when the UltraWand is run using off-label cooling methods (gravity saline flow instead of pump) that cooling flow to one or both cells can be decreased based on pressure applied by the physician to the device. To reflect this information to the user, the Atrial Fibrillation Division (AFD) has
- 2009-01-30TerminatedOther
Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System.
Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit.
- Open, ClassifiedProcess control
Cardioblate CryoFlex Surgical Ablation Console
There is potential for intermittent electrical connectivity between the console and probe.
- TerminatedUnder Investigation by firm
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 with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- TerminatedUnder Investigation by firm
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 Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- TerminatedUnder Investigation by firm
Cardioblate 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 Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- TerminatedUnder Investigation by firm
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 Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Monitor surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue automatically
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