Venclose System digiRF Generator VCRFG1Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00858254006022), received between Jan 30, 2023 and Aug 25, 2026 — classified as 24 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (28 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, K250068, 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 16, 2026.

Recalls naming this device

1. Aug 21, 2025Open, Classified

   Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.

   Z-2638-2025 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Communication or Transmission Problem

  On (b)(6) 2025, a patient underwent a radiofrequency venous ablation procedure using the Venclose System digiRF Generator. It was reported that the device displayed an error. Additional information was received stating device displayed a red X and error 53 when three different catheters were connected. The catheters worked fine when used with a different generator. Additional information was received, stating that the Venclose Generator was received at the service center with 3.35 software version installed. This confirms that the generator was operating on software version 3.35 when the Red X with Error 53 was displayed at the facility. The issue occurred during use but there was no reported injury to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50427831 ↗
• MalfunctionAug 18, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50292954 ↗
• MalfunctionJul 15, 2026Communication or Transmission Problem

  It was reported that the facility had a failed catheter when used with this Venclose Generator. The generator was confirmed to be in software version 3.35. Additional information was provided stating that during a procedure on (b)(6) 2026, using this Venclose generator, a Red X error with Error 53 was displayed immediately after the catheter was connected. The catheter had not yet been inserted into the vein when the error occurred. The target treatment location was the great saphenous vein (GSV); the affected side was not specified. There was no patient involvement or impact reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25823550 ↗
• MalfunctionMay 19, 2026Communication or Transmission Problem

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE GENERATOR. PRIOR TO THE PROCEDURE, THE VENCLOSE GENERATOR DISPLAYED A RED X AT CATHETER INITIALIZATION AFTER FLUSHING. VENCLOSE GENERATOR IS IN 3.35 SOFTWARE VERSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212380 ↗
• MalfunctionMay 19, 2026Communication or Transmission Problem

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE GENERATOR. PRIOR TO THE PROCEDURE, THE VENCLOSE GENERATOR DISPLAYED A RED X AT CATHETER INITIALIZATION AFTER FLUSHING. VENCLOSE GENERATOR IS IN 3.35 SOFTWARE VERSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212377 ↗
• MalfunctionApr 7, 2026Communication or Transmission Problem

  A PATIENT UNDERWENT A RADIOFREQUENCY ABLATION PROCEDURE USING THE VENCLOSE SYSTEM DIGIRF GENERATOR. DURING PROCEDURE, IT WAS REPORTED THAT WHEN A VENCLOSE CATHETER WAS OPENED AND PLUGGED INTO THE VENCLOSE GENERATOR, IT STARTED TO DISPLAY ERROR 53 NOT RECOGNIZING THE CATHETER. GENERATOR IS IN SOFTWARE VERSION 3.35. ADDITIONAL INFORMATION WAS PROVIDED AND STATING THERE WAS A LARGE RED X WITH ERROR CODE 53. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797113 ↗
• MalfunctionMar 16, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION PROCEDURE USING THE VENCLOSE SYSTEM DIGIRF GENERATOR. IT WAS REPORTED THAT THE CATHETERS DID NOT WORK AND WERE IT WAS THROWING A RED X WHEN CONNECTED TO THE VENCLOSE GENERATOR. RECEIVED CONFIRMATION FROM THE FACILITY A DAY LATER STATING THE GENERATOR IS RUNNING IN 3.35 SOFTWARE VERSION. ADDITIONAL INFORMATION WAS RECEIVED STATING OCCURRED DURING CATHETER INITIALIZATION. THE PATIENT WAS TREATED WITH AN ADDITIONAL CATHETER THAT WORKED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602931 ↗
• MalfunctionMar 16, 2026Communication or Transmission Problem

  A patient underwent a radiofrequency ablation procedure using the Venclose System digiRF Generator. During the procedure, it was reported that the catheters did not work and it was throwing a Red X when connected to the Venclose Generator. Received confirmation from the facility a day later stating the generator is running in 3.35 software version. Additional information was received stating that the issue occurred during catheter initialization. The Venclose generator displayed Red X during 5 different procedures, 4 on Wednesday Feb 18 and 1 the week before. The patient was treated with an additional catheter that worked. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602930 ↗
• MalfunctionMar 16, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION PROCEDURE USING THE VENCLOSE SYSTEM DIGIRF GENERATOR. IT WAS REPORTED THAT THE CATHETERS DID NOT WORK AND WERE IT WAS THROWING A RED X WHEN CONNECTED TO THE VENCLOSE GENERATOR. RECEIVED CONFIRMATION FROM THE FACILITY A DAY LATER STATING THE GENERATOR IS RUNNING IN 3.35 SOFTWARE VERSION. ADDITIONAL INFORMATION WAS RECEIVED STATING OCCURRED DURING CATHETER INITIALIZATION. THE PATIENT WAS TREATED WITH AN ADDITIONAL CATHETER THAT WORKED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602895 ↗
• MalfunctionMar 16, 2026Communication or Transmission Problem

  A patient underwent a radiofrequency ablation procedure using the Venclose System digiRF Generator. During the procedure, it was reported that the catheters did not work and it was throwing a Red X when connected to the Venclose Generator. Received confirmation from the facility a day later stating the generator is running in 3.35 software version. Additional information was received stating that the issue occurred during catheter initialization. The Venclose generator displayed Red X during 5 different procedures, 4 on Wednesday Feb 18 and 1 the week before. The patient was treated with an additional catheter that worked. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602894 ↗
• MalfunctionMar 16, 2026Communication or Transmission Problem

  A patient underwent a radiofrequency ablation procedure using the Venclose System digiRF Generator. During the procedure, it was reported that the catheters did not work and it was throwing a Red X when connected to the Venclose Generator. Received confirmation from the facility a day later stating the generator is running in 3.35 software version. Additional information was received stating that the issue occurred during catheter initialization. The patient was treated with an additional catheter that worked. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602893 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITYS FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206864 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITYS FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206863 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITYS FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206665 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITY'S FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206664 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITYS FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206662 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITYS FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206661 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITYS FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206654 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITYS FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206653 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT) FOLLOWING A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE GENERATOR. THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITY¿S FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206608 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITYS FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206607 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT) FOLLOWING A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE GENERATOR. THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITY¿S FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206606 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITYS FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206605 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITYS FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206604 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE PERFORMED USING THE VENCLOSE CATHETER IN CONJUNCTION WITH THE VENCLOSE SYSTEM DIGIRF GENERATOR. THE FACILITY REPORTED THAT THIS PATIENT DEVELOPED AN ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT). THE EVENT WAS IDENTIFIED POST PROCEDURE DURING THE FACILITYS FOLLOW UP ASSESSMENT. NO ADDITIONAL PATIENT SPECIFIC CLINICAL DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24206603 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160754, K250068, K252316. One submission often covers many models, so check the product and lot details in each record.

• Z-0371-2025 · Sep 4, 2024 · Open, Classified
  The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to perma