ClosureFast™ CF7-3-60 (UDI 00643169862944)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169862944), received between Dec 22, 2020 and Dec 10, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT TWO OUT OF THREE TRAYS OF CATHETERS WERE NOT IN STERILE PACKAGING. THE HEALTHCARE PROVIDER STATED THAT THE TRAYS WERE RECEIVED FROM A THIRD-PARTY VENDOR, AND WHILE ONE TRAY AND CATHETER WERE IN STERILE PACKAGING, THE OTHER TWO WERE NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892273 ↗
• MalfunctionDec 10, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT TWO OUT OF THREE TRAYS OF CATHETERS WERE NOT IN STERILE PACKAGING. THE HEALTHCARE PROVIDER STATED THAT THE TRAYS WERE RECEIVED FROM A THIRD-PARTY VENDOR, AND WHILE ONE TRAY AND CATHETER WERE IN STERILE PACKAGING, THE OTHER TWO WERE NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892264 ↗
• MalfunctionNov 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  A CLOSUREFAST CATHETER WAS INTENDED TO BE USED. IT WAS REPORTED THE JUST THE STERILE TRAY CAME IN THE BOX ALONE, NO STERILE PACKAGING. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE TABS ON THE OUTER BOX WERE SEALED. A SECOND CLOSUREFAST DEVICE WAS OPENED AND THE SAME ISSUE WAS NOTED. ANOTHER CLOSUREFAST WAS USED TO COMPLETE THE CASE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706998 ↗
• MalfunctionNov 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  A CLOSUREFAST CATHETER WAS INTENDED TO BE USED. IT WAS REPORTED THE JUST THE STERILE TRAY CAME IN THE BOX ALONE, NO STERILE PACKAGING. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE TABS ON THE OUTER BOX WERE SEALED. A SECOND CLOSUREFAST DEVICE WAS OPENED AND THE SAME ISSUE WAS NOTED. ANOTHER CLOSUREFAST WAS USED TO COMPLETE THE CASE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706812 ↗
• MalfunctionOct 4, 2023Use of Device Problem; Use of Device Problem

  A PHYSICIAN USED A CLOSUREFAST CATHETER TO TREAT THE RIGHT SMALL SAPHENOUS VEIN OF A PATIENT. THE CATHETER EXPIRED ON 31 JULY 2023. NO ISSUES WITH THE DEVICE FUNCTIONALITY AND THE PATIENT HAS NOT EXPERIENCED ANY HARMS TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869922 ↗
• MalfunctionDec 22, 2020Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

  PHYSICIAN INTENDED TO USE A CLOSUREFAST CATHETER WITH AN RFG3 DURING TREATMENT OF THE PATIENT¿S SHORT SAPHENOUS VEIN (SSV). IFU WAS FOLLOWED. A TEMPERATURE ISSUE IS REPORTED. IT IS REPORTED THE CATHETER TEMPERATURE INCREASED ONLY FROM 24 DEGREE TO 26 DEGREES. NO ERROR CODES WERE DISPLAYED. THE EVENT OCCURRED IN THE PATIENT'S BLOOD VESSEL. THE CATHETER WAS REPLACED TO COMPLETE THE PROCEDURE. THE DEVICE WAS USED POST EXPIRY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11053850 ↗