Micropuncture G47940Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00827002479401), received between Jun 17, 2016 and Oct 27, 2025 — classified as 12 injuries, 10 malfunctions.

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

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391815 ↗
• InjuryMay 29, 2025Break; Break

  AS REPORTED, DURING A FISTULAGRAM OF THE LEFT ARM, A MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S SHEATH SEPARATED. THE MICROPUNCTURE SET AND WIRE WERE INSERTED INTO THE ACCESS SITE, WHICH WAS REPORTEDLY NORMAL. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE DEVICE; HOWEVER, UPON WITHDRAWAL OF THE DEVICE, THE SHEATH TORE, LEAVING A FRAGMENT INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE FRAGMENT VIA A CUT-DOWN. PER THE REPORTER, A SMALL ADDITIONAL INCISION WAS MADE, THE WIRE WAS PULLED, AND THE TORN SHEATH FRAGMENT WAS SUCCESSFULLY RETRIEVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105005 ↗
• MalfunctionJun 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB SEPARATED FROM A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S SHEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17074690 ↗
• InjuryAug 3, 2022Break; Break

  AS REPORTED, WHILE ATTEMPTING TO GAIN INTRAVENOUS ACCESS IT THE LEFT BRACHIAL VEIN, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S CATHETER TIP AND WIRE SEPARATED. THE SEPARATED CATHETER AND TIP WERE RETRIEVED BY THE PHYSICIAN. THERE WAS NO HARM TO THE PATIENT. IT IS UNKNOWN HOW THE FRAGMENTS WERE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15158665 ↗
• InjuryFeb 11, 2022Break; Unraveled Material; Break; Unraveled Material

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13514100 ↗
• InjuryDec 8, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S WIRE UNRAVELED AND SEPARATED. THE SEPARATED PORTION REMAINS IN THE PATIENT'S SUBCUTANEOUS TISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12962818 ↗
• MalfunctionJun 15, 2021Material Separation; Material Separation

  AS REPORTED, THE END OF AN UNSPECIFIED COMPONENT OF A MICROPUNCTURE TRANSITIONLESS ACCESS SET SEPARATED DURING ADVANCEMENT INTO THE PATIENT. THE SEPARATED FRAGMENT WAS ABLE TO BE RETRIEVED, AND THE PROCEDURE WAS COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999209 ↗
• MalfunctionOct 27, 2020Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED ON 20JAN2021: ACCESS WAS GAINED IN THE ABDOMEN THROUGH THE DAVINCI TROCAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10739354 ↗
• InjuryAug 31, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 31AUG2020. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY VIA A CALCIFIED GROIN. THE DEVICE WAS INTENDED TO FACILITATE PLACEMENT OF A LARGER WIRE. RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE DEVICE. THE WIRE GUIDE WAS EITHER MANIPULATED OR REMOVED THROUGH THE ENTRY NEEDLE. THE DEVICE DID NOT KINK. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10472134 ↗
• MalfunctionJun 10, 2020Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138258 ↗
• MalfunctionJan 7, 2020Unraveled Material; Unraveled Material

  AS REPORTED, WHILE OBTAINING ACCESS FOR A UNKNOWN PROCEDURE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET UNRAVELED IN THE PATIENT' BODY. NOTHING WAS LEFT INSIDE THE BODY, AND ANOTHER COOK MICROPUNCTURE SET WAS USED TO RE-ACCESS THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9559030 ↗
• MalfunctionDec 18, 2019Unraveled Material; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490819 ↗
• InjuryDec 11, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9451126 ↗
• MalfunctionJun 13, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695673 ↗
• MalfunctionMay 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633598 ↗
• InjuryNov 14, 2018Material Separation; Material Separation

  IT WAS REPORTED, A (B)(6) MALE WITH MEDICAL HISTORY OF END STAGE RENAL DISEASE (ESRD) CURRENTLY ON PERITONEAL DIALYSIS (PD), WAS UNDERGOING A PERMCATH PLACEMENT FOR HIS CONVERSION FROM PD TO HEMODIALYSIS. DURING THE PROCEDURE THE MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS INSERTED VIA THE LEFT JUGULAR VEIN AND THE GUIDE WIRE AND SHEATH WERE POSITIONED BY FLUOROSCOPIC GUIDANCE. THERE WAS NO RESISTANCE REPORTED OR TORQUE APPLIED. THE PATIENT'S ANATOMY WAS DESCRIBED AS NORMAL WITHOUT CALCIFICATION OR TORTUOSITY. AFTER THE MICRO SHEATH WAS REMOVED OVER THE WIRE, THE PHYSICIAN NOTED IT WAS NOT INTACT. A 5 CM X 2 MM PIECE OF THE MICRO SHEATH WAS OBSERVED IN THE AREA OF THE PATIENT'S LEFT PULMONARY ARTERY. ACCORDING TO THE COMPLAINANT, SEVERAL MEMBERS OF THE HEALTH TEAM WERE CONSULTED AND DETERMINED THE FRACTURED PART OF THE SHEATH COULD NOT TRAVEL ANY FURTHER AND COULD BE LEFT IN PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. NO INFORMATION WAS PROVIDED REGARDING ANY OCCURRENCE OF VESSEL SPASM. MEDICATIONS ADMINISTERED DURING THE PROCEDURE WERE 5000UNITS (U) OF HEPARIN. THE PATIENT WAS REFERRED TO ANOTHER FACILITY WHERE, ACCORDING TO THE COMPLAINANT, A BLIND ATTEMP

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8068862 ↗
• InjuryMay 29, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A CORONARY ANGIOGRAM, THE SHEATH OF THE MICROPUNCTURE TRANSITIONLESS ACCESS SET GOT STUCK IN THE PATIENT 'S FEMORAL ARTERY AND HAD TO BE SURGICALLY REMOVED. APPROACH FOR CORONARY ANGIOGRAM PROCEDURE WAS MADE VIA THE RIGHT FEMORAL ARTERY. INSERTION OF THE COMPLAINT DEVICE WAS NOT DIFFICULT. THE PATIENT'S ANATOMY WAS NEITHER CALCIFIED, SCARRED, NOR TORTUROUS. AT AN UNSPECIFIED POINT IN THE PROCEDURE, THE COMPLAINT DEVICE BECAME LODGED IN THE PATIENT'S ANATOMY AND COULD NOT BE REMOVED VIA THE ENDOVASCULAR APPROACH. THE ANGIOGRAM PROCEDURE WAS NOT COMPLETED IN ORDER FOR THE PATIENT TO BE BROUGHT TO THE OPERATING ROOM WHERE THE DISTAL PORTION OF THE COMPLAINT DEVICE (IN IT'S ENTIRETY) WAS SURGICALLY REMOVED. THE REMOVAL WAS SUCCESSFUL AND THE PATIENT WAS REPORTEDLY "FINE". AFTER REMOVAL, NO SECTION OF THE COMPLAINT DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7550129 ↗
• InjuryMar 22, 2018Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  PER USER FACILITY VOLUNTARY MEDWATCH (B)(4), "PATIENT WAS ADMITTED FOR PAIN IN LEFT LEG AND SOME IN THE RIGHT LEG WHILE WALKING, CONSISTENT WITH PERIPHERAL CLAUDICATION. DURING AN ATTEMPTED INTERVENTION OF AN OCCLUDED STENT, THE TIP OF A [MICROPUNCTURE TRANSITIONLESS ACCESS SET] WIRE BROKE OFF IN THE PATIENT WAS ENTRAPPED BETWEEN THE STENT AND THE ARTERIAL WALL. EXCERPTS FROM THE PROCEDURAL RECORD: ULTRASOUND, FLUOROSCOPIC GUIDANCE USED TO OBTAIN ACCESS TO THE [LEFT] POPLITEAL ARTERY USING MICROPUNCTURE WITH MICROSHEATH PLACEMENT VIA MODIFIED SELDINGER TECHNIQUE. THERE WAS DIFFICULTY ADVANCING THE MICROWIRE AND PART OF THE MICROWIRE WAS FRACTURED WITH A PIECE INSIDE THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) STENT. COMPLICATION MENTIONED: MICROPUNCTURE WIRE PIECE REMAINS IN VESSEL (LEFT DISTAL SUPERFICIAL FEMORAL ARTERY)." FOLLOWING SEPARATION OF THE MICROPUNCTURE WIRE, ANOTHER MANUFACTURER'S GLIDEWIRE (STIFF SHAFT ANGLED 0.035 INCH (IN) DIAMETER) WAS ADVANCED INTO THE 4 FRENCH (FR) MICROPUNTURE SET INTRODUCER. THE 4 FR INTRODUCER WAS THEN REMOVED. A COOK MEDICAL 0.035 INCH (IN) DIAMETER CROSSCATH SUPPORT CATHETER WAS THEN ADVANCED OVER THE STIFF SHAFT GLIDEWIRE INTO THE DISTAL SF

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7361429 ↗
• MalfunctionMar 7, 2018Break; Fracture

  PATIENT ADMITTED FOR PAIN IN LEFT LEG AND SOME IN THE RIGHT LEG WHILE WALKING, CONSISTENT WITH PERIPHERAL CLAUDICATION. DURING AN ATTEMPTED INTERVENTION OF AN OCCLUDED STENT, THE TIP OF A WIRE BROKE OFF IN THE PATIENT AND WAS ENTRAPPED BETWEEN THE STENT AND THE ARTERIAL WALL. EXCERPTS FROM PROCEDURAL RECORD: ULTRASOUND, FLUOROSCOPIC GUIDANCE USED TO OBTAIN ACCESS TO THE POPLITEAL ARTERY USING A MICROPUNCTURE WITH MICROSHEATH PLACEMENT VIA MODIFIED SELDINGER TECHNIQUE. THERE WAS DIFFICULTY ADVANCING THE MICROWIRE AND PART OF THE MICROWIRE WAS FRACTURED WITH A PIECE INSIDE THE DISTAL SFA STENT. COMPLICATION: MICROPUNCTURE WIRE PIECE REMAINS IN VESSEL (LEFT DISTAL SUPERFICIAL FEMORAL ARTERY).

  Patient problems: Pain

  MAUDE report 7320415 ↗
• InjuryAug 31, 2017Break; Break

  A MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT, DURING THE PROCEDURE, THE INTRODUCER SHEATH BROKE OFF IN THE PATIENT'S LEG. A CUT DOWN WAS PERFORMED TO REMOVE THE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6833945 ↗
• InjuryOct 17, 2016Break; Sticking; Break; Sticking

  IT WAS REPORTED THAT DURING AN ATTEMPT TO REMOVE THE WIRE GUIDE FROM THE RIGHT COMMON FEMORAL ARTERY DURING A CORONARY RIGHT HEART CATHETERIZATION PROCEDURE, THE WIRE GUIDE BECAME STUCK IN PLAQUE AND 1.5 CM OF THE TIP OF A WIRE GUIDE BROKE INSIDE THE PATIENT. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR REMOVAL OF THE SEPARATED FRAGMENT. HOWEVER, INFORMATION WAS PROVIDED THAT AT THIS POINT, THE FACILITY DECIDED TO LEAVE THE BROKEN FRAGMENT INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6033067 ↗
• InjuryJun 17, 2016Material Separation; Material Separation

  THE PHYSICIAN NUMBED AREA TO BE ACCESSED, MADE SMALL NICK WITH BLADE, INSERTED MPIS NEEDLE INTO JUGULAR VEIN. NEXT HE INSERTED THE MPIS WIRE INTO THE NEEDLE, THEN REMOVED THE NEEDLE. HE THEN PLACED THE SHEATH/DILATOR COAXIAL SET OVER THE WIRE INTO THE VEIN, THEN REMOVED BOTH THE INNER DILATOR AND WIRE TOGETHER. NEXT HE INSERTED THE .035 J WIRE FROM THE BARD SET THROUGH THE ACCESS SHEATH. WHEN HE ATTEMPTED TO PULL THE ACCESS SHEATH OUT, THE SHEATH SNAPPED ABOUT 1/3 OF THE WAY DISTAL FROM THE HUB, WITH 2/3 REMAINING INSIDE THE VESSEL. PHYSICIAN THEN CUT DOWN THE ACCESS SITE A LITTLE MORE, INSERTED AN 8F SHEATH OVER THE WIRE, AND INSERTED A SNARE ALONG SIDE THE WIRE THROUGH THE SAME SHEATH. HE THEN SNARED THE END OF THE J WIRE, WHICH HAD THE MPIS PIECE STILL OVER IT, AND REMOVED EVERYTHING AT ONCE. THE CASE WAS ABLE TO BE COMPLETED WITH THE PATIENT HAVING THE TRIALYSIS CATHETER SUCCESSFULLY PLACED. PATIENT IS FINE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE ACCESS SITE REQUIRED FURTHER CUT DOWN AND A SNARE WAS USED TO REMOVE THE BROKEN PORTION OF THE

  Patient problems: No Code Available

  MAUDE report 5733331 ↗