ClosureFast Micro Introducer Sheath MIS-7F07Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00886333227532), received between Jan 8, 2024 and Aug 12, 2026 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

5 other recalls cover devices cleared under the same FDA submission (K780126); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Break

  It was reported that during a vein closure procedure using the Micro Introducer 7F 7CM 7FX7CM, a floopy part of the wire broke off inside the patient¿s vein and a portion of the sheath was left inside the patient. The event involved the right distal great saphenous vein. Local anesthesia was utilized, and a guidewire was used for insertion. The instructions for use were followed without issue, no resistance was encountered when advancing the device, and no packaging issues were noted. An x-ray was ordered to assess the retained fragment(s). The vein closure procedure was completed and the vein was reported as closed.

  Patient problems: Foreign Body In Patient

  MAUDE report 50225567 ↗
• InjuryJun 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE MICRO INTRODUCER INTRODUCER/PUNCTURE KIT INVOLVING A PERIPHERAL VEIN (GREAT SAPHENOUS VEIN, DISTAL), PART OF THE FLOPPY TIP OF THE .018 ACCESS WIRE DETACHED IN VIVO IN A TRIBUTARY VEIN. A WIRE FRAGMENT MEASURING APPROXIMATELY 3¿4 CM WAS RETAINED IN THE PATIENT¿S LEG AND COULD NOT BE RETRIEVED OR REMOVED DURING THE PROCEDURE, AND THE PROCEDURE WAS ABORTED. LOCAL ANESTHESIA WAS UTILIZED, THE LUMEN WAS FLUSHED PRIOR TO USE. THE PATIENT WAS REPORTED ALIVE WITH INJURY, AND REFERRAL TO VASCULAR SURGERY FOR REMOVAL OF THE RETAINED WIRE FRAGMENT WAS PLANNED. THE SAMPLE IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25414175 ↗
• InjuryMay 8, 2026Break

  IT WAS REPORTED THAT THE INTRODUCER WAS USED DURING VASCULAR ACCESS AND THE GUIDEWIRE DETACHED IN VIVO, LEAVING A FRAGMENT IN THE RIGHT PROXIMAL GREAT SAPHENOUS VEIN. ACCESS WAS OBTAINED IN THE RIGHT POSTERIOR ACCESSORY VEIN WITHOUT ISSUE, AND THE GUIDEWIRE WAS ADVANCED EASILY INTO THE VEIN WITHOUT RESISTANCE. A 7FR SHEATH WITH DILATOR WAS ADVANCED OVER THE WIRE AND PLACED IN THE VEIN, AND THE DILATOR AND GUIDEWIRE WERE REMOVED WITHOUT RESISTANCE. ULTRASOUND IMAGING THEN SHOWED FOREIGN MATERIAL IN THE VEIN, AND IT WAS IDENTIFIED AS PART OF THE GUIDEWIRE. THE PROVIDER ABORTED THE PLANNED VENASEAL PROCEDURE AND PERFORMED A PHLEBECTOMY TO REMOVE THE GUIDEWIRE FRAGMENT. THE DETACHED COMPONENT WAS SUCCESSFULLY REMOVED, AND INSPECTION SHOWED THE FLOPPY PART OF THE GUIDEWIRE HAD SEPARATED. THE VEIN WAS REPORTED TO HAVE CLOSED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25130926 ↗
• InjuryMar 30, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE MICRO INTRODUCER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE MICROWIRE IN THE LEFT MID GREAT SAPHENOUS VEIN. THE FLOPPY PORTION OF THE MICROWIRE (FLEXIBLE FLAT CABLE) DETACHED IN VIVO, RESULTING IN A RETAINED FOREIGN BODY IN THE SUBCUTANEOUS TISSUE. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM. IMAGING WITH X-RAY WAS CONDUCTED, AND AN INTERVENTIONAL RADIOLOGY PROCEDURE WAS PERFORMED TO LOCATE AND REMOVE THE RETAINED WIRE SEGMENT WITH FORCEPS. LOCAL ANESTHESIA WAS UTILIZED. NO PATIENT INJURY, COMPLAINTS, OR INSTABILITY WERE REPORTED POST-REMOVAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24715130 ↗
• InjurySep 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A DELAY IN SURGERY OCCURRED DUE TO THE MICRO INTRODUCER 7F X 7CM KITS STICKING SIGNIFICANTLY. THE PHYSICIAN DESCRIBED THE WHITE PART OF THE SHEATH AS BLUNT AND NOT ENTERING THE VEIN EASILY, WHICH NECESSITATED MAKING A WIDER OR LARGER SKIN INCISION TO ADVANCE THE SHEATH INTO THE VEIN. THE PROCEDURE WAS COMPLETED USING THE MIS-7F07 KIT DESPITE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23066957 ↗
• InjurySep 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A DELAY IN SURGERY OCCURRED DUE TO THE MICRO INTRODUCER 7F X 7CM KITS STICKING SIGNIFICANTLY. THE PHYSICIAN DESCRIBED THE WHITE PART OF THE SHEATH AS BLUNT AND NOT ENTERING THE VEIN EASILY, WHICH NECESSITATED MAKING A WIDER OR LARGER SKIN INCISION TO ADVANCE THE SHEATH INTO THE VEIN. THE PROCEDURE WAS COMPLETED USING THE MIS-7F07 KIT DESPITE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23066724 ↗
• MalfunctionJul 3, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT THE LEFT GREAT SAPHENOUS VEIN IN A PATIENT, SEVERAL ISSUES OCCURRED. THE VEIN WAS ACCESSED AT THE PROXIMAL THIGH AROUND 12 CM FROM THE SAPHENOFEMORAL JUNCTION (SFJ), AND THE CLOSUREFAST 7F 100CM CATHETER WAS POSITIONED 2.7 CM FROM THE SFJ. TUMESCENT INFILTRATION, LOCAL ANESTHESIA AND COMPRESSION WERE UTILIZED. DURING THE FIRST TREATMENT LOCATED AT THE #11 ON THE CATHETER, AN ADVISORY MESSAGE OF "LOW TEMPERATURE, HIGH POWER ADJUST COMPRESSION" APPEARED WITH 11 SECONDS LEFT, AND THE TREATMENT WATTAGE DID NOT DROP BELOW 20 WATTS WITHIN THE FIRST 10 SECONDS. ADDITIONAL HAND COMPRESSION WAS APPLIED, AND THE MESSAGE RESOLVED. THE SAME WATTAGE ISSUE OCCURRED DURING THE SECOND TREATMENT. THE TEAM WAS INFORMED, AND A THIRD TREATMENT WAS PERFORMED WITH ULTRASOUND PROBE COMPRESSION AND FINGER COMPRESSION, AFTER WHICH PARAMETERS WERE ESTABLISHED. A FOURTH TREATMENT WAS PERFORMED TO ENSURE ADEQUATE TREATMENT AT THE SAPHENOFEMORAL JUNCTION. SUBSEQUENT TREATMENTS AT THE #7 MARK ON THE CATHETER MET ALL PARAMETERS WITHOUT FURTHER ADVISORY MESSAGES. A LOT OF RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE MICRO INTRODUCER 7F 7CM SHEATH. THE NURSE PRACTIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22400475 ↗
• MalfunctionJul 1, 2025Crack; Crack

  IT WAS REPORTED THAT DURING TREATMENT OF A LESION IN THE RIGHT MID GREAT SAPHENOUS VEIN USING RADIOFREQUENCY ABLATION WITH THE MICRO INTRODUCER 7F 7CM 7FX7CM, THE HUB OF THE ACCESS NEEDLE IN THE INTRODUCER KIT DEVELOPED A CRACK, WHICH RESULTED IN LEAKAGE AND ALLOWED AIR INTO THE SYRINGE WHEN ASPIRATING. THE ISSUE OCCURRED ON 3 MICRO INTRODUCERS. THE PROCEDURE INVOLVED SIX RADIOFREQUENCY CYCLES, WITH TUMESCENT INFILTRATION, LOCAL ANESTHESIA, AND COMPRESSION WITH A TRANSDUCER UTILIZED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE SAMPLES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22376245 ↗
• MalfunctionMay 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT WITH THE 45CM .018¿ GUIDEWIRE FROM MIS-7F07 KIT DURING TREATMENT OF THE PATIENTS LEFT PROXIMAL GREAT SAPHENOUS VEIN (GSV). MINIMAL VESSEL TORTUOSITY WAS REPORTED. VEIN DIAMETER REPORTED AS 32MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE LUMEN WAS FLUSHED PRIOR TO USE. TUMESCENT INFILTRATION WAS NOT UTILIZED. NO ANESTHESIA WAS UTILIZED. NO COMPRESSION WAS USED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. REMOVAL DIFFICULTIES WERE REPORTED. ACCESS TO VEIN OCCURRED WITHOUT RESISTANCE BUT WHEN THE INTRODUCER, DILATOR AND SHEATH WERE REMOVED, THERE WAS NO RESISTANCE BUT PROVIDER NOTICED THE FLOPPY PART OF THE INTRODUCER ACCESS WIRE WAS LEFT BEHIND IN THE VEIN WHEN VIEWED UNDER ULTRASOUND. PROCEDURE WAS ABORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19314648 ↗
• MalfunctionApr 23, 2024Break; Break

  PHYSICIAN INTENDED TO USE A MICRO INTRODUCER KIT DURING PATIENT TREATMENT. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE LUMEN WAS FLUSHED PRIOR TO USE. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANESTHESIA WAS UTILIZED. TRANSDUCER COMPRESSION WAS USED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE VALVE NOT WORKING PROPERLY ON SHEATH, BLOOD WAS LEAKING EVERYWHERE AND THEN SHEATH BROKE APART WHEN PULLING OUT. DEVICE WAS PULLED WITH RESISTANCE AND REMOVED SUCCESSFULLY WITHOUT INJURY/INTERVENTION. THIS ISSUE IS REPORTED FOR 2 KITS. NO VESSEL DAMAGE NOTED. A REPLACEMENT DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19164077 ↗
• MalfunctionMar 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT DURING PATIENT TREATMENT. THE LUMEN WAS FLUSHED PRIOR TO USE. A GUIDEWIRE WAS USED FOR THE INSERTION OF THE CATHETER. LOCAL ANESTHESIA WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED BLOOD LEAKED OUT THE ORANGE HUB WHEN GUIDEWIRE AND DILATOR WERE REMOVED. THIS ISSUE IS REPORTED FOR 3 KITS IN A ROW. THE DEVICES WERE SAFELY REMOVED FROM PATIENT. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. THE VEIN IS REPORTED TO HAVE CLOSED AND NO ADDITIONAL TREATMENT WAS REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937610 ↗
• InjuryJan 8, 2024Difficult to Advance; Difficult to Advance

  A MICRO INTRODUCER SHEATH WAS TO BE USED DURING TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). THE PHYSICIAN NOTICED 5 SHEATHS THAT WERE EXTREMELY DIFFICULT TO PUSH THE CATHETER THROUGH THE SHEATH. THE IFU WAS FOLLOWED. PHYSICIAN CONCERNED THAT THE CATHETER COULD KINK OR BREAK OFF, ONCE FORCED CATHETER THROUGH AND A "POP" WAS FELT AND AN ABNORMAL AMOUNT OF BLOOD LOSS OCCURRED THROUGH THE VALVE OF THE SHEATH. THE PROCEDURE WAS FINISHED USING THE SHEATH BUT THE BLOOD LOSS WAS NOT NORMAL. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18464928 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K780126. One submission often covers many models, so check the product and lot details in each record.

• Z-2705-2026 · Jun 1, 2026 · Open, Classified
  One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
• Z-2806-2020 · Jun 19, 2020 · Terminated
  ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or
• Z-1938-2020 · Apr 8, 2020 · Terminated
  PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedu
• Z-1029-2016 · Feb 17, 2016 · Terminated
  ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and
• Z-0764-2010 · Jan 6, 2009 · Terminated
  Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA f