ClosureFast MIS-7F07Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521140295), received between Apr 30, 2020 and Dec 14, 2023 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, 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 ↗
• 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 ↗
• 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. A GUIDEWIRE WAS USED FOR INSERTION OF CATHETER. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANESTHESIA WAS USED. COMPRESSION WAS NOT USED. IT IS REPORTED WHEN PHYSICIAN TRIED TO REMOVE WIRE FROM PATIENT THE WIRE BROKE IN HALF. THE PHYSICIAN WAS ABLE TO USE FORCEPS TO REMOVE THE REMAINING PART OF THE WIRE FROM THE PATIENT. THEY DID HAVE TO STITCH THE PATIENT UP AT THE ACCESS SITE AFTER THE PROCEDURE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16501768 ↗
• InjuryMar 1, 2023Break; Fracture; Break; Fracture

  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 NOT UTILIZED. LOCAL ANESTHESIA WAS USED. COMPRESSION WAS NOT USED. IT IS REPORTED THE WIRE TIP FRACTURED AND WAS LEFT IN GSV. THE TIP OF WIRE WAS ALSO BENT. PROCEDURE WAS CANCELLED AND PATIENT WAS SENT TO ER FOR SURGICAL REMOVAL OF TIP OF WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16458181 ↗
• InjurySep 19, 2022Material Fragmentation

  PHYSICIAN ATTEMPTED TO USE A MICRO INTRODUCER KIT DURING TREATMENT OF THE 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. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANESTHESIA WAS USED. HAND COMPRESSION WAS USED. IT IS REPORTED THE GUIDE WIRE BROKE OFF AT THE TIP OF ABOUT 1 CM IN LENGTH AND REMAINED IN VEIN WHEN WIRE WAS PULLED OUT. PHYSICIAN HAD TO DO AN ADDITIONAL STABLECTOMY TO CUT THAT PORTION OF THE VEIN OUT AND WERE ABLE TO RETRIEVE THE BROKEN SEGMENT. THE DEVICE WAS USED SUCCESSFULLY. ALL PIECES WERE ACCOUNTED FOR. 11 SEGMENTS WERE TREATED AND VEIN IS REPORTED TO HAVE CLOSED SUCCESSFULLY. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15446790 ↗
• MalfunctionOct 8, 2020Break

  PHYSICIAN INTENDED TO USE A 7FR MICRO INTRODUCER SHEATH DURING AN RFA PROCEDURE TO TREAT THE PATIENT¿S SHORT SAPHENOUS VEIN (SSV). IFU WAS FOLLOWED. NO VISIBLE DAMAGE WAS NOTED TO THE MICRO INTRODUCER SHEATH. IT IS REPORTED THE RFA PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE VESSEL WAS CLOSED BUT FOLLOWING THE PROCEDURE OF THE RIGHT SMALL SAPHENOUS VEIN, IT WAS NOTED THAT A SMALL PIECE OF THE 0.018 WIRE FROM THE MIS7F-07 SHEATH WAS MISSING FROM THE WIRE (FLOPPY TIP) IN THE PATIENTS SMALL SAPHENOUS VEIN. THE PHYSICIAN IMMEDIATELY ATTEMPTED TO IDENTIFY UNDER ULTRASOUND, BUT IT WAS NOT PRESENT IN THE PATIENT¿S VEIN. PHYSICIAN COULD NOT DETERMINE IF THE WIRE WAS LOCATED IN THE PATIENT¿S SOFT TISSUE AS THE WIRE TIP IS EXTREMELY SMALL. THEREFORE, THE PHYSICIAN ADVISED DETERMINING WHETHER THERE WAS ANY PIECE OF THE WIRE OR FOREIGN BODY PRESENT IN THE PATIENT¿S SOFT TISSUE OF THE RIGHT CALF. THE PIECE OF WIRE WAS RETRIEVED FROM THE PATIENT THE SAME DAY. UNDER FLUOROSCOPY OF THE RIGHT LEG, A FOREIGN BODY WHICH APPEARED OF A PIECE OF WIRE WAS IDENTIFIED IN THE PATIENT¿S RIGHT CALF. WITH A 1-2 CM INCISION IN THE RIGHT CALF OVER THE FOREIGN BODY UNDER FLUOROSCOPY PHYSICIAN DISSECTED THE SMALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10651039 ↗
• MalfunctionSep 10, 2020Material Separation

  FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10513427 ↗
• MalfunctionJul 22, 2020Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A MICRO INTRODUCER DURING PROCEDURE. THE LUMEN WAS FLUSHED PRIOR TO USE. IFU WAS FOLLOWED. A GUIDE WIRE WAS USED FOR THE INSERTION OF THE CATHETER. IT WAS REPORTED THAT WHEN DILATOR WAS REMOVED AFTER SHEATH INSERTION, THE SHAFT POPPED OFF THE HUB OF DILATOR. PHYSICIAN WAS ABLE TO GRASP THE SHAFT ALONG WITH WIRE AND REMOVE OUT OF SHEATH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311885 ↗
• MalfunctionJul 17, 2020Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A MICRO INTRODUCER KIT DURING PATIENT TREATMENT. IFU WAS FOLLOWED. IT IS REPORTED THE SHEATH SEPARATED FROM THE DILATOR HUB. THE DEVICE COULD NOT BE USED SUCCESSFULLY BUT ALL PIECES WERE ACCOUNTED FOR. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290902 ↗
• MalfunctionJun 2, 2020Material Separation

  FOLLOW UP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10113108 ↗
• MalfunctionApr 30, 2020Break

  FOLLOW UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10014005 ↗

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