ClosureFast™ CF7-3-60 (UDI 00763000702298)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000702298), received between Jun 19, 2025 and Oct 22, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING TREATMENT OF VENOUS INSUFFICIENCY IN THE ANTERIOR LATERAL ACCESSORY VEIN USING THE CLOSUREFAST CATHETER, THE VEIN DID NOT CLOSE AFTER THE INITIAL TREATMENT. THE CATHETER LUMEN WAS FLUSHED PRIOR TO USE. THE CATHETER OVERHEATED TO 150 DEGREES CELSIUS, AND THE GENERATOR DISPLAYED AN ERROR MESSAGE INDICATING THAT THE TREATMENT WAS STOPPED DUE TO EXCESSIVELY HIGH TEMPERATURE. THE ERROR OCCURRED WITHIN THE FIRST CYCLE OF TREATMENT. COMPRESSION WAS UTILIZED. THE PHYSICIAN STARTED A CYCLE OUTSIDE THE BODY AGAIN JUST TO CHECK IF THE ERROR OCCURS AGAIN AND IT HAPPENED. TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WERE UTILIZED, AND HAND COMPRESSION WAS APPLIED. THERE WAS NO PARAMETERS CHANGED ON THE GENERATOR. ANOTHER CATHETER WAS USED WITHIN THE SAME PROCEDURE TO COMPLETE THE TREATMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355275 ↗
• InjuryJun 19, 2025Overheating of Device; Deformation Due to Compressive Stress; Overheating of Device; Deformation Due to Compressive Stress

  PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CF7-3-60 TO TREAT A PATIENT. THE PREPARATION OF THE CATHETER, USE OF THE DEVICE, AND POST-USAGE PROCEDURES WAS PERFORMED IN ACCORDANCE WITH THE PACKAGE INSERT AND THE USER MANUAL. THE CATHETER LUMEN WAS FLUSHED PRIOR TO USE. THE GUIDEWIRE WAS USED DURING CATHETER INSERTION AND PLACEMENT. THE TEMPERATURE AT THE TIME OF HEAT GENERATION INCREASED TO THE SET TEMPERATURE. IT WAS REPORTED, FOR ONE LESION, TWO PUNCTURES WERE MADE TO TREAT IT, AND AFTER CAUTERIZING THE AREA NEAR THE GROIN, THE CATHETER WAS REMOVED FROM THE BODY, WHEREUPON IT WAS DISCOVERED THAT THE METAL COIL HAD BECOME KINKED. AS THE KINKED PART HAD ALSO BECOME SCORCHED, IT WAS DECIDED TO REFRAIN FROM FURTHER USE AND TO REPLACE THE CATHETER. IT IS UNCLEAR WHETHER THE CATHETER WAS ALREADY KINKED AT THE TIME IT WAS REMOVED. ANOTHER CATHETER WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL TREATMENT WAS REQUIRED. NO INJURY TO THE PATIENT AS A RESULT OF THE ISSUE/SCORCHED CATHETER. COMPRESSION WAS BEING APPLIED WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289224 ↗