ClosureFastRecalls & reported problems across all models

We found 6 models of ClosureFast by Covidien LP in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2017 and Dec 14, 2023 — classified as 11 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ClosureFast problems

ClosureFast models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ClosureFast MIS-7F07

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  23 reports
• ClosureFast CF7-7-100

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  19 reports
• ClosureFast CF7-7-60

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  8 reports
• ClosureFast IS-7F11

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  1 report
• ClosureFast MIS-7F11

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  1 report
• ClosureFast MPK-4F

  Percutaneous sheath introducer kit
  1 report

Recent ClosureFast adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A MIS-7F07 TO TREAT A LESION. THE LUMEN WAS FLUSHED PRIOR TO USE. IFU WAS FOLLOWED. A GUIDEWIRE WAS NOT USED FOR THE INSERTION OF THE CATHETER. GUIDEWIRE SHEARED OFF AND FRACTURED IN THE PATIENTS VEIN. CASE ABORTED. ALL PIECES ACCOUNTED FOR. PATIENT WILL RETURN ON A FUTURE DATE TO COMPLETE CASE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333121 ↗
• MalfunctionDec 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT DURING PATIENT TREATMENT. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED THE VALVE STAYED OPEN WHEN THEY PULLED OUT THE DILATER AND 018 WIRE BEFORE THEY PUT THE CATHETER IN AND THE PATIENT BLEED EVERYWHERE. A REPLACEMENT MIS-7F07 KIT WAS USED TO COMPLETE PROCEDURE. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18308008 ↗
• MalfunctionDec 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT DURING PATIENT TREATMENT. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED THE VALVE STAYED OPEN WHEN THEY PULLED OUT THE DILATER AND 018 WIRE BEFORE THEY PUT THE CATHETER IN AND THE PATIENT BLEED EVERYWHERE. A REPLACEMENT MIS-7F07 KIT WAS USED TO COMPLETE PROCEDURE. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18307998 ↗
• MalfunctionDec 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT DURING PATIENT TREATMENT. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED THE VALVE STAYED OPEN WHEN THEY PULLED OUT THE DILATER AND 018 WIRE BEFORE THEY PUT THE CATHETER IN AND THE PATIENT BLEED EVERYWHERE. A REPLACEMENT MIS-7F07 KIT WAS USED TO COMPLETE PROCEDURE. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18307993 ↗
• MalfunctionDec 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT DURING PATIENT TREATMENT. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED THE VALVE STAYED OPEN WHEN THEY PULLED OUT THE DILATER AND 018 WIRE BEFORE THEY PUT THE CATHETER IN AND THE PATIENT BLEED EVERYWHERE. A REPLACEMENT MIS-7F07 KIT WAS USED TO COMPLETE PROCEDURE. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18307988 ↗
• MalfunctionDec 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT DURING PATIENT TREATMENT. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED THE VALVE STAYED OPEN WHEN THEY PULLED OUT THE DILATER AND 018 WIRE BEFORE THEY PUT THE CATHETER IN AND THE PATIENT BLEED EVERYWHERE. A REPLACEMENT MIS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18307980 ↗
• MalfunctionDec 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT DURING PATIENT TREATMENT. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED THE VALVE STAYED OPEN WHEN THEY PULLED OUT THE DILATER AND 018 WIRE BEFORE THEY PUT THE CATHETER IN AND THE PATIENT BLEED EVERYWHERE. A REPLACEMENT MIS-7F07 KIT WAS USED TO COMPLETE PROCEDURE. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18307972 ↗
• MalfunctionDec 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT DURING PATIENT TREATMENT. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED THE VALVE STAYED OPEN WHEN THEY PULLED OUT THE DILATER AND 018 WIRE BEFORE THEY PUT THE CATHETER IN AND THE PATIENT BLEED EVERYWHERE. A REPLACEMENT MIS-7F07 KIT WAS USED TO COMPLETE PROCEDURE. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18307969 ↗
• MalfunctionDec 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT DURING RFA TREATMENT OF PATIENTS GREAT SAPHENOUS VEIN (GSV) & ANTERIOR ACCESSORY GREAT SAPHENOUS VEIN (AAGSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. A GUIDEWIRE WAS USED FOR INSERTION OF CATHETER. TUMESCENT INFILTRATION WAS UTILIZED. HAND COMPRESSION WAS USED. PHYSICIAN ACCESSED LEFT BELOW THE KNEE GSV AND AS HE WAS REMOVING THE DILATOR AND WIRE, HE NOTICED THE MICROTIP ON THE WIRE WAS MISSING. PHYSICIAN SCANNED THE LEG WITH ULTRASOUND AND VISUALIZED THE TIP OF THE WIRE WAS PARTIALLY IN THE VEIN AND THE REMAINDER OF THE WIRE SUCCESSFULLY CAME OUT OF THE BODY INSIDE THE SHEATH. PHYSICIAN ATTEMPTED TO GAIN ACCESS TO THE WIRE TIP BUT COULD NOT ACCESS THE RETAINED WIRE. ALL PIECES ARE NOT ACCOUNTED FOR. PROCEDURE WAS COMPLETED WITH AN RF CATHETER. THE VEIN IS REPORTED TO HAVE CLOSED. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18292476 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT DURING TREATMENT OF PATIENTS GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. LOCAL ANESTHESIA WAS USED. HAND COMPRESSION WAS USED. PHYSICIAN ACCESSED THE PATIENT'S GSV AND INSERTED THE WIRE AND SHEATH WITH NO RESISTANCE OR ANY ISSUES WHATSOEVER. PHYSICIAN THEN WENT TO MOVE THE SHEATH BACK AND THE ENTIRE SHAFT (WHITE PART OF SHEATH) CAME APART WHILE INSIDE THE PATIENT. THE PHYSICIAN AND THE ULTRASOUND TECH SCANNED THROUGHOUT THE ENTIRE LEG, WHICH PHYSICIAN COMMENTED HAD GREAT VISUALIZATION. PHYSICIAN ALSO MENTIONED THE PATIENT WAS REALLY TALL AND NO ANATOMICAL ISSUES OR LARGE BODY HABITUS. THIS HAPPENED IN THE BEGINNING OF THE PROCEDURE BEFORE TUMESCENT. THEY WERE UNABLE TO LOCATE ANY OBJECT IN THE PATIENTS VEIN AND THEN SEARCHED THE ENTIRE ROOM (BED, FLOOR, EVERYWHERE) TO LOCATE THE MISSING PIECE BUT WERE NOT ABLE TO FIND IT ANYWHERE. IT IS PRESUMABLY INSIDE THE PATIENT. THE PHYSICIAN THEN PULLED ANOTHER SHEATH AND COMPLETED THE PROCEDURE WITHOUT ANY ISSUES. THERE IS STILL NO ANSWER AS TO WHERE THIS PIECE WENT. 1 SEGMENT WAS TRE

  Patient problems: Foreign Body In Patient; Foreign Body Reaction

  MAUDE report 18253149 ↗
• MalfunctionOct 2, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A MICRO INTRODUCER KIT DURING TREATMENT OF PATIENT¿S GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. A GUIDEWIRE WAS USED FOR INSERTION OF THE CATHETER. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANAESTHESIA WAS USED. HAND COMPRESSION WAS USED. IT IS REPORTED PATIENTS RIGHT GSV WAS TORTUOUS AND REQUIRED THREE ACCESS POINTS AFTER PHYSICIAN WAS UNABLE TO NAVIGATE WITH CATHETER OR WIRE. ACCESS WAS OBTAINED VIA DISTAL CALF, BELOW KNEE AND MID-THIGH. MID-THIGH TO SFJ WAS TREATED ACCORDING TO IFU. PHYSICIAN THEN ATTEMPTED TO INSERT CATHETER INTO ACCESS SITE BELOW KNEE AND WHILE ATTEMPTING TO NAVIGATE GSV PULLED OUT THE INTRODUCER LOOSENING ACCESS. INTRODUCER WAS RE-PREPPED, AND ACCESS WAS OBTAINED AGAIN IN THE SAME LOCATION, WHEN REMOVING THE DILATOR AND WIRE IT WAS NOTICED THAT A PORTION OF THE ACCESS WIRE WAS NO LONGER ATTACHED. WIRE WAS ATTEMPTED TO BE LOCATED WITH ULTRASOUND BUT WAS UNABLE TO BE SEEN. INTRODUCER WAS REMOVED AND FLUSHED BUT WIRE WAS STILL NOT SEEN. PROCEDURE WAS STOPPED AFTER IT WAS NOTICED THAT A PORTION OF THE WIRE WAS MISSING UPON REMO

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858289 ↗
• MalfunctionOct 2, 2023Break; Break

  A PHYSICIAN WAS ATTEMPTING TO USE A MICRO INTRODUCER SHEATH FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). THE IFU WAS FOLLOWED. IT WAS REPORTED WHILE ACCESSING THE VEIN, THE PHYSICIAN NOTICED THAT THE WIRE TIP WAS ALREADY PRE BENT. THE PHYSICIAN DECIDED TO ACCESS AND BELIEVES THAT THE BENT WIRE TIP GRABBED ONTO A VEIN VALVE AND BROKE OFF INTO THE PATIENT. IT WAS DECIDED TO GO FORWARD WITH THE ABLATION TO GO AHEAD A CLOSE OFF THE VEIN, THAT WAY THE PIECE OF THE WIRE COULD NOT TRAVEL INTO THE DEEP VENOUS SYSTEM. ABLATION WAS COMPLETE SUCCESSFULLY AND PATIENT WAS SCHEDULED WITH VASCULAR SURGERY TO HAVE WIRE TIP REMOVED. THAT PROCEDURE WAS DONE SUCCESSFULLY AND NO PATIENT INJURY WAS REPORTED. PHYSICIAN IS NOT COMFORTABLE USING SHEATHS FROM THAT LOT NUMBER AND IS REQUESTING ALL 75 BE REPLACED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858242 ↗
• InjuryMar 23, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  THE WIRE WAS CUT OFF INTO PATIENT VEIN. VEIN SIZE WAS VERY SMALL. PHYSICIAN TRIED TO ACCESS ABOVE VEIN HOWEVER IT WENT INTO SPASM. THE PROCEDURE WAS ABORTED.

  Patient problems: Foreign Body In Patient; Perforation of Vessels

  MAUDE report 16598685 ↗
• InjuryMar 8, 2023Break; Break

  PHYSICIAN INTENDED TO USE A MICRO INTRODUCER KIT DURING TREATMENT OF PATIENTS GREAT SAPHENOUS VEIN (GSV). THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. A GUIDEWIRE WAS USED FOR INSERTION OF CATHETER. TUMESCENT INFILTRATION WAS NOT UTILIZED. LOCAL ANESTHESIA WAS USED. COMPRESSION WAS NOT USED. IT IS REPORTED THE 0.018 STAINLESS STEEL ACCESS GUIDEWIRE BROKE IN HALF INSIDE THE PATIENT LEG UPON ACCESS AS THE PHYSICIAN WAS REMOVING IT FROM THE ACCESS SITE ALONG W THE BLUE DILATOR. PATIENT COMPLAINED OF PAIN. ALL PIECES WERE ACCOUNTED FOR. A REPLACEMENT GUIDEWIRE WAS USED TO COMPLETE PROCEDURE AND VEIN IS REPORTED TO HAVE CLOSED. NO ADDITIONAL TREATMENT REQUIRED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 16503147 ↗
• MalfunctionMar 8, 2023Break; Break

  PHYSICIAN INTENDED TO USE A MICRO INTRODUCER KIT DURING TREATMENT OF PATIENTS GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANESTHESIA WAS USED. COMPRESSION WAS NOT USED. IT IS REPORTED THE ACCESS WIRE BROKE. PHYSICIAN WAS ABLE TO RETRIEVE IT WITH A ¼ INCISION. PROCEDURE WAS COMPLETED BY USING VARITHENA. 1 SEGMENT WAS TREATED AND VEIN IS REPORTED TO HAVE CLOSED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16501804 ↗

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