Venclose System EVSRF Catheter VC10A256F60Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00858254006008), received between Apr 1, 2020 and Sep 29, 2026 — classified as 1 death, 26 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (17 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K160754, K252316); 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. Sep 4, 2024Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, 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 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 ↗
• InjuryOct 30, 2025Insufficient Heating; Insufficient Heating

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE EVSRF CATHETER. DURING THE PROCEDURE, THE TUMESCENT ADMINISTRATION, THE TEMPERATURE DID NOT DECREASE BELOW 30-DEGREE CELSIUS AND THE PATIENT REPORTED EXPERIENCING PAIN. REPORTEDLY, THE CATHETER WAS REMOVED AND INSERTED A EVLT INSTEAD AND COMPLETED THE CASE SUCCESSFULLY WITHOUT ISSUE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 23422341 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213330 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213317 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213315 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213273 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213272 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. PRIOR TO THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213271 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213270 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. PRIOR TO THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213269 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213267 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213266 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. PRIOR TO THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213264 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213262 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213172 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE GENERATOR SCREEN DISPLAYED A RED X WHEN THE CATHETER WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213171 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160754, K252316. One submission often covers many models, so check the product and lot details in each record.

• Z-2638-2025 · Aug 21, 2025 · Open, Classified
  Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiR