Venclose System EVSRF Catheter VC10A256F100Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00858254006015), received between Aug 2, 2020 and Jul 13, 2026 — classified as 31 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (14 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 52 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 24467798 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE ACCOUNT EXPERIENCED MULTIPLE EHITS FOLLOWING PROCEDURES WITH NEWLY REINTRODUCED CATHETERS, TOTALING AT LEAST SIX INCIDENTS IN THE PAST MONTH. ALL CATHETERS USED WERE NEW SINCE MARKET RETURN. RVT CONFIRMED APPLYING PRESSURE ALONG THE CATHETER¿S HEATING ELEMENT DURING TREATMENT, WITH TWO BURNS NOTED AT THE PROXIMAL END. PRE TREATMENT MEASUREMENTS AVERAGED 6.8 CM FROM THE TERMINAL VALVE AT THE SFJ TO THE CATHETER TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24143436 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE ACCOUNT EXPERIENCED MULTIPLE EHITS FOLLOWING PROCEDURES WITH NEWLY REINTRODUCED CATHETERS, TOTALING AT LEAST SIX INCIDENTS IN THE PAST MONTH. ALL CATHETERS USED WERE NEW SINCE MARKET RETURN. RVT CONFIRMED APPLYING PRESSURE ALONG THE CATHETER¿S HEATING ELEMENT DURING TREATMENT, WITH TWO BURNS NOTED AT THE PROXIMAL END. PRE TREATMENT MEASUREMENTS AVERAGED 6.8 CM FROM THE TERMINAL VALVE AT THE SFJ TO THE CATHETER TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24143435 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE ACCOUNT EXPERIENCED MULTIPLE EHITS FOLLOWING PROCEDURES WITH NEWLY REINTRODUCED CATHETERS, TOTALING AT LEAST SIX INCIDENTS IN THE PAST MONTH. ALL CATHETERS USED WERE NEW SINCE MARKET RETURN. RVT CONFIRMED APPLYING PRESSURE ALONG THE CATHETER¿S HEATING ELEMENT DURING TREATMENT, WITH TWO BURNS NOTED AT THE PROXIMAL END. PRE TREATMENT MEASUREMENTS AVERAGED 6.8 CM FROM THE TERMINAL VALVE AT THE SFJ TO THE CATHETER TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24143433 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE ACCOUNT EXPERIENCED MULTIPLE EHITS FOLLOWING PROCEDURES WITH NEWLY REINTRODUCED CATHETERS, TOTALING AT LEAST SIX INCIDENTS IN THE PAST MONTH. ALL CATHETERS USED WERE NEW SINCE MARKET RETURN. RVT CONFIRMED APPLYING PRESSURE ALONG THE CATHETER¿S HEATING ELEMENT DURING TREATMENT, WITH TWO BURNS NOTED AT THE PROXIMAL END. PRE TREATMENT MEASUREMENTS AVERAGED 6.8 CM FROM THE TERMINAL VALVE AT THE SFJ TO THE CATHETER TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24143432 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE ACCOUNT EXPERIENCED MULTIPLE EHITS FOLLOWING PROCEDURES WITH NEWLY REINTRODUCED CATHETERS, TOTALING AT LEAST SIX INCIDENTS IN THE PAST MONTH. ALL CATHETERS USED WERE NEW SINCE MARKET RETURN. RVT CONFIRMED APPLYING PRESSURE ALONG THE CATHETER¿S HEATING ELEMENT DURING TREATMENT, WITH TWO BURNS NOTED AT THE PROXIMAL END. PRE TREATMENT MEASUREMENTS AVERAGED 6.8 CM FROM THE TERMINAL VALVE AT THE SFJ TO THE CATHETER TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24143233 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE ACCOUNT EXPERIENCED MULTIPLE EHITS FOLLOWING PROCEDURES WITH NEWLY REINTRODUCED CATHETERS, TOTALING AT LEAST SIX INCIDENTS IN THE PAST MONTH. ALL CATHETERS USED WERE NEW SINCE MARKET RETURN. RVT CONFIRMED APPLYING PRESSURE ALONG THE CATHETER¿S HEATING ELEMENT DURING TREATMENT, WITH TWO BURNS NOTED AT THE PROXIMAL END. PRE TREATMENT MEASUREMENTS AVERAGED 6.8 CM FROM THE TERMINAL VALVE AT THE SFJ TO THE CATHETER TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24143231 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE ACCOUNT EXPERIENCED MULTIPLE EHITS FOLLOWING PROCEDURES WITH NEWLY REINTRODUCED CATHETERS, TOTALING AT LEAST SIX INCIDENTS IN THE PAST MONTH. ALL CATHETERS USED WERE NEW SINCE MARKET RETURN. RVT CONFIRMED APPLYING PRESSURE ALONG THE CATHETER¿S HEATING ELEMENT DURING TREATMENT, WITH TWO BURNS NOTED AT THE PROXIMAL END. PRE TREATMENT MEASUREMENTS AVERAGED 6.8 CM FROM THE TERMINAL VALVE AT THE SFJ TO THE CATHETER TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24143230 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE ACCOUNT EXPERIENCED MULTIPLE EHITS FOLLOWING PROCEDURES WITH NEWLY REINTRODUCED CATHETERS, TOTALING AT LEAST SIX INCIDENTS IN THE PAST MONTH. ALL CATHETERS USED WERE NEW SINCE MARKET RETURN. RVT CONFIRMED APPLYING PRESSURE ALONG THE CATHETER¿S HEATING ELEMENT DURING TREATMENT, WITH TWO BURNS NOTED AT THE PROXIMAL END. PRE TREATMENT MEASUREMENTS AVERAGED 6.8 CM FROM THE TERMINAL VALVE AT THE SFJ TO THE CATHETER TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24143229 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE ACCOUNT EXPERIENCED MULTIPLE EHITS FOLLOWING PROCEDURES WITH NEWLY REINTRODUCED CATHETERS, TOTALING AT LEAST SIX INCIDENTS IN THE PAST MONTH. ALL CATHETERS USED WERE NEW SINCE MARKET RETURN. RVT CONFIRMED APPLYING PRESSURE ALONG THE CATHETER¿S HEATING ELEMENT DURING TREATMENT, WITH TWO BURNS NOTED AT THE PROXIMAL END. PRE TREATMENT MEASUREMENTS AVERAGED 6.8 CM FROM THE TERMINAL VALVE AT THE SFJ TO THE CATHETER TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24143227 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE CATHETER. DURING THE PROCEDURE, THE ACCOUNT EXPERIENCED MULTIPLE EHITS FOLLOWING PROCEDURES WITH NEWLY REINTRODUCED CATHETERS, TOTALING AT LEAST SIX INCIDENTS IN THE PAST MONTH. ALL CATHETERS USED WERE NEW SINCE MARKET RETURN. RVT CONFIRMED APPLYING PRESSURE ALONG THE CATHETER¿S HEATING ELEMENT DURING TREATMENT, WITH TWO BURNS NOTED AT THE PROXIMAL END. PRE TREATMENT MEASUREMENTS AVERAGED 6.8 CM FROM THE TERMINAL VALVE AT THE SFJ TO THE CATHETER TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24143015 ↗
• MalfunctionNov 25, 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 ALLEGEDLY DISPLAYED "ERROR 51 WITH RED X" CODE WHEN CATHETER WAS PLUGGED INTO GENERATOR. THE CATHETER WAS USING SOFTWARE VERSION 3.35 THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644507 ↗
• MalfunctionNov 25, 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 ALLEGEDLY DISPLAYED "ERROR 51 WITH RED X" CODE WHEN CATHETER WAS PLUGGED INTO GENERATOR. THE CATHETER WAS USING SOFTWARE VERSION 3.35 THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644494 ↗
• MalfunctionNov 25, 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 ALLEGEDLY DISPLAYED "ERROR 51 WITH RED X" CODE WHEN CATHETER WAS PLUGGED INTO GENERATOR. THE CATHETER WAS USING SOFTWARE VERSION 3.35 THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644493 ↗
• MalfunctionNov 25, 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 ALLEGEDLY DISPLAYED "ERROR 51 WITH RED X" CODE WHEN CATHETER WAS PLUGGED INTO GENERATOR. THE CATHETER WAS USING SOFTWARE VERSION 3.35 THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644490 ↗
• MalfunctionNov 25, 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 ALLEGEDLY DISPLAYED "ERROR 51 WITH RED X" CODE WHEN CATHETER WAS PLUGGED INTO GENERATOR. THE CATHETER WAS USING SOFTWARE VERSION 3.35 THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644489 ↗
• MalfunctionNov 25, 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 ALLEGEDLY DISPLAYED "ERROR 51 WITH RED X" CODE WHEN CATHETER WAS PLUGGED INTO GENERATOR. THE CATHETER WAS USING SOFTWARE VERSION 3.35 THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644487 ↗
• MalfunctionNov 25, 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 ALLEGEDLY DISPLAYED "ERROR 51 WITH RED X" CODE WHEN CATHETER WAS PLUGGED INTO GENERATOR. THE CATHETER WAS USING SOFTWARE VERSION 3.35 THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644485 ↗
• MalfunctionNov 25, 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 ALLEGEDLY DISPLAYED "ERROR 51 WITH RED X" CODE WHEN CATHETER WAS PLUGGED INTO GENERATOR. THE CATHETER WAS USING SOFTWARE VERSION 3.35 THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644484 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT APPROXIMATELY THREE MONTHS AND FOUR DAYS LATER POST RADIOFREQUENCY ABLATION PROCEDURE, THE PATIENT REPORTEDLY HAD CHEST PAIN. LATER THE PATIENT ALSO UNDERWENT ROBOT-ASSIST KNEE REPLACEMENT. THE ADVERSE EVENT OF CHEST PAIN WAS NOT RELATED TO THE DEVICE OR PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Chest Pain

  MAUDE report 23422214 ↗

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