Venclose System EVSRF CatheterRecalls & reported problems across all models
Venclose Inc · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Venclose System EVSRF Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 120
- Deaths reported
- 1
- Injuries reported
- 57
- Recalls
- 1
We found 2 models of Venclose System EVSRF Catheter by Venclose Inc in the FDA's device registry (GUDID). Together they are named in 120 adverse event reports in the FDA's MAUDE database, received between Apr 1, 2020 and Sep 29, 2026 — classified as 1 death, 57 injuries, 62 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (31 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Venclose System EVSRF Catheter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 4, 2024Open, Classified
The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature.
Z-0371-2025 · Root cause: Employee error · names 2 of these models · Recall details · FDA record ↗
Most reported Venclose System EVSRF Catheter problems
Device problems
- Adverse Event Without Identified Device or Use Problem41
- Communication or Transmission Problem31
- Insufficient Heating13
- Excessive Heating12
- Thermal Decomposition of Device11
- Break7
- Inappropriate or Unexpected Reset7
- Material Deformation6
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- Burn(s)20
- Thrombosis/Thrombus15
- Pain9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Swelling/ Edema3
- Ulcer3
- Electric Shock2
Venclose System EVSRF Catheter models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Venclose System EVSRF Catheter VC10A256F60Electrosurgical, Cutting & Coagulation & Accessories1 recall1 death68 reports
- Venclose System EVSRF Catheter VC10A256F100Electrosurgical, Cutting & Coagulation & Accessories1 recall52 reports
Recent Venclose System EVSRF Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Thermal Decomposition of Device; Smoking
On (b)(6) 2026, a patient underwent a radio frequency ablation procedure using the venclose catheter. During the procedure, the device functioned properly for several treatment cycles; however, during the final treatment cycle, it began smoking and emitted a burnt odor. Treatment was terminated early, and the coil was found unraveled upon removal from the patient. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929314 ↗MalfunctionSep 16, 2026Break
On (b)(6)2026, a patient underwent a radio frequency ablation procedure using the venclose catheter. Prior to the procedure, the catheter tip broken. The procedure was completed using another catheter. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785178 ↗MalfunctionSep 14, 2026Break; Material Deformation
On (b)(6) 2026, a patient underwent a radiofrequency ablation procedure using a Venclose catheter. During device insertion, a kink was observed in the catheter; however, the kinked portion remained outside the patient. It was further reported that the catheter material subsequently fractured completely. The procedure was completed successfully without any reported complications. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749281 ↗MalfunctionSep 10, 2026Tear, Rip or Hole in Device Packaging; Communication or Transmission Problem
A patient underwent a radiofrequency ablation procedure using a Venclose catheter. During the procedure, it was found that the battery was depleted, the 60 cm catheter was not recognized by the generator when connected, and a hole was observed in the package. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716238 ↗InjuryAug 10, 2026Contamination; Material Deformation; Excessive Heating
On (b)(6) 2026, a patient underwent a radiofrequency ablation procedure using the Venclose catheter. During the procedure, the catheter allegedly heated above the temperature displayed on the generator, and a thick clot formed on the tip of the catheter that could not be removed as expected. Additionally, Patient experienced pain and presented to the Emergency Department; ultrasound showed no EHITT or DVT. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 50190625 ↗InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem
On (b)(6)2026, a patient underwent a radiofrequency ablation procedure using the Venclose catheter. Following the procedure, the patient experienced second degree burns and presented to a general practitioner the following day. The patient status is unknown.
Patient problems: Burn(s)
MAUDE report 25794280 ↗InjuryJul 2, 2026Insufficient Heating; Nonstandard Device; Difficult to Remove
On (b)(6) 2026, a female patient underwent a radio frequency ablation procedure using the Venclose catheter. During the procedure, it was reported that upon initiation, the catheter failed to reach adequate temperature for effective treatment, with the generator displaying abnormal blue line patterns. During the final treatment cycle, the catheter was difficult to withdraw, with partial intimal tissue disruption observed. Patient experienced an atypical sensation during treatment; no electrical shock reported. Additionally, the generator displayed inconsistent cycle data, recording 160 seconds of treatment with only 5 cycles, indicating inaccurate cycle counting. The procedure was completed using the same catheter. The patient was reported to be stable, with no reported patient injury. The patient was scheduled for follow up with the hospital, including repeat imaging, to determine whether any additional treatment would be necessary.
Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions
MAUDE report 25690477 ↗MalfunctionJun 9, 2026Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING TO THE PROCEDURE, THE SEPARATION OF CATHETER OUTER COMPONENTS RESULTING IN EXPOSURE OF INTERNAL COMPONENTS. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25440063 ↗MalfunctionJun 4, 2026Self-Activation or Keying
ON (B)(6) 2026, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING TO THE PROCEDURE, THE CATHETER INITIATED AUTOMATIC TREATMENT WITHOUT ACTIVATION AFTER SETUP; DEVICE WAS PROMPTLY DISCONNECTED FROM THE GENERATOR. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25387305 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED BURN. THE PATIENT STATUS IS UNKNOWN.
Patient problems: Burn(s)
MAUDE report 25226663 ↗InjuryMay 7, 2026Insufficient Heating
ON (B)(6) 2026, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE CATHETER TEMPERATURE FLUCTUATED BETWEEN ONE HUNDRED TWENTY DEGREES AND ONE HUNDRED THIRTY DEGREES CELSIUS, THEN DROPPED BACK TO HUNDRED DEGREES CELSIUS. BLUE SQUIGGLY LINES APPEARED AFTER EACH BURN. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 25110825 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRAIL (B)(4) OF A VENCLOSE DEVICE, THAT POST ENDOVENOUS RADIOFREQUENCY ABLATION PROCEDURE ON THE TARGET LEFT LIMB GREATER SAPHENOUS VEIN, THE SUBJECT WAS OBSERVED WITH OCCLUSION ON THE TARGET VESSEL AND UNDERWENT ADJUNCTIVE PROCEDURE. IT WAS FURTHER REPORTED THAT, APPROXIMATELY FOUR MONTHS AND TWENTY-NINE DAYS LATER ON (B)(6) 2025, THE SUBJECT HAD EDEMA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Swelling/ Edema
MAUDE report 24594138 ↗MalfunctionFeb 27, 2026Communication or Transmission Problem; Packaging Problem
A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X POPPED UP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24467854 ↗MalfunctionFeb 27, 2026Communication or Transmission Problem
A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X POPPED UP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24467801 ↗MalfunctionFeb 27, 2026Communication or Transmission Problem
A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X POPPED UP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24467800 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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