ClosureFast CF7-7-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521058071), received between Apr 4, 2017 and Jan 15, 2019 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2019Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE THE CLOSUREFAST CATHETER WITH A RFG2 GENERATOR AS PER IFU. NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. IT WAS REPORTED THE CATHETER COULD NOT BE CONNECTED TO THE RFG2 DUE TO PIN DAMAGE. IT WAS REPORTED THAT THE PINS WERE BENT AND THEY DID NOT REMAIN ON THE CONNECTOR AND SOME REMAINED IN THE RECEPTACLE. IT WAS ALSO REPORTED THAT THE HEATING COIL WAS BENT. ANOTHER DEVICE WAS USED WITH THE SAME RFG2 FOR THE PROCEDURE. NO ALLEGATION AGAINST THE RFG2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8247604 ↗
• MalfunctionMar 22, 2018Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER TO CARRY OUT AN ABLATION PROCEDURE OF AN UNKNOWN VESSEL. AFTER 3 ABLATIONS IT WAS INDICATED THAT THE TEMPERATURE WAS RAISED AND IMPEDANCE DROPPED, HOWEVER, WHEN CHECKED ON ECHO, THE SITE WAS NOT ABLATED AT ALL. THERE WAS NO BURN MARK CONFIRMED BY ECHO. ANOTHER CATHETER WAS USED TO COMPLETE THE CASE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7361059 ↗
• InjuryMay 31, 2017Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A CLOSUREFAST CATHETER FOR A RADIOFREQUENCY ABLATION PROCEDURE. CATHETER DEFECT OCCURRED DURING TREATMENT. CUSTOMER CANNOT REMEMBER IF THERE WERE ANY ERROR CODES/MESSAGES/WARNINGS FROM THE GENERATOR. IT WAS REPORTED THAT THERE WAS NO OUTPUT FROM THE CATHETER SO ABLATION COULD NOT BE PERFORMED. NO PATIENT INJURY REPORTED. PROCEDURE WAS CONVERTED TO VEIN STRIPPING.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6603764 ↗
• MalfunctionMay 31, 2017Delamination; Delamination

  THE PHYSICIAN USED A CLOSUREFAST CATHETER FOR RADIOFREQUENCY ABLATION PROCEDURE. IT WAS REPORTED THE PHYSICIAN ABLATED ONE SIDE OF THE LEG, THE CATHETER WAS REMOVED FROM THE PATIENT; ATTEMPTS WERE MADE TO FLUSH THE CATHETER BEFORE REINSERTION BUT FOUND TO BE OCCLUDED. ANOTHER CATHETER WAS USED TO TREAT THE PATIENT WITHOUT ANY ISSUES NOTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6600177 ↗
• MalfunctionMay 26, 2017Material Deformation; Material Deformation

  A CLOSUREFAST CATHETER WAS USED FOR A RADIOFREQUENCY ABLATION PROCEDURE. THE LESION SITE WAS 40CM. IT WAS REPORTED THAT DURING USE, MESSAGES ¿TREATMENT HALTED NON-UNIFORM TEMPERATURE "AND ¿14 SECONDS WITHIN TARGET TEMPERATURE RANGES ¿ APPEARED BEFORE REACHING 20 SECOND. THE UNIT STARTED TO WORK PROPERLY LATER AND IT PERFORMED ABLATION A FEW TIMES AS USUAL BUT ANOTHER PRODUCT WAS USED JUST IN CASE. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6593222 ↗
• InjuryMay 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN WAS ATTEMPTING TO TREAT VENOUS INSUFFICIENCY IN THE GREAT SAPHENOUS VEIN (GSV) USING A CLOSUREFAST RADIOFREQUENCY ABLATION CATHETER. IT WAS REPORTED THAT THE CATHETER WAS NOT RESPONDING/ NOT RECOGNIZED BY THE GENERATOR. TEST WAS PERFORMED WITH TWO OTHER CATHETERS AND BOTH DID NOT WORK. PHYSICIAN THEN PERFORMED SAPHENECTOMY, AN OPEN SURGERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6542848 ↗
• InjuryMay 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN WAS ATTEMPTING TO TREAT VENOUS INSUFFICIENCY IN THE GREAT SAPHENOUS VEIN (GSV) USING A CLOSUREFAST RADIOFREQUENCY ABLATION CATHETER. IT WAS REPORTED THAT THE CATHETER WAS NOT RESPONDING/ NOT RECOGNIZED BY THE GENERATOR. TEST WAS PERFORMED WITH TWO OTHER CATHETERS AND BOTH DID NOT WORK. PHYSICIAN THEN PERFORMED SAPHENECTOMY, AN OPEN SURGERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6542843 ↗
• MalfunctionApr 4, 2017Material Deformation; Material Deformation

  PHYSICIAN TREATED PATIENT USING A CLOSUREFAST CATHETER. IT IS REPORTED THE TREATMENT WAS COMPLETED SUCCESSFULLY WITH NO PRODUCT PERFORMANCE ISSUES EXPERIENCED. TEMPERATURE AND WATTS WERE OPTIMAL. AFTER TREATMENT, IT WAS NOTED THE HEATING ELEMENT WAS CHARRED IN THE MIDDLE. SOME DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED PAIN IN THE TREATED LEG. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 6456048 ↗