Micropuncture G48002Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00827002480025), received between Nov 5, 2014 and Nov 12, 2025 — classified as 21 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (18 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Break; Break

  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 23534455 ↗
• MalfunctionJul 28, 2025Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION RECEIVED 30JUL2025. AS REPORTED, THE INTENDED PROCEDURE WAS "FEMORAL ARTERIAL ACCESS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22632158 ↗
• MalfunctionMay 28, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 02JUN2025. AFTER THE HUB SEPARATED, PART OF THE SHEATH REMAINED OUTSIDE THE BODY; THEREFORE, THE PHYSICIAN WAS ABLE TO REMOVE THE SEPARATED PORTION INTACT, WITHOUT COMPLICATIONS OR PATIENT HARM. FLUOROSCOPY WAS USED TO CONFIRM THAT THE ENTIRE SHEATH HAD BEEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096030 ↗
• MalfunctionAug 23, 2024Unraveled Material; Unraveled Material

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

  Patient problems: Insufficient Information

  MAUDE report 20050454 ↗
• InjuryJul 24, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 30JUL2024. THE WIRE WAS NOT ALTERED PRIOR TO USE. THE PATIENT'S VESSELS WERE REPORTEDLY SMALL, AND THE PATIENT WAS RECEIVING VASOPRESSORS. ACCESS WAS OBTAINED IN THE RIGHT RADIAL ARTERY USING ULTRASOUND GUIDANCE, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE. RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE WIRE. THE USER ATTEMPTED TO PULL THE WIRE BACK; HOWEVER, RESISTANCE WAS ENCOUNTERED. THE WIRE THEN UNRAVELED AND SEPARATED, LEAVING A PORTION OF THE WIRE IN THE VESSEL. PER THE REPORTER, THE WIRE WAS NOT PULLED BACK OR MANIPULATED THROUGH A NEEDLE OR OTHER METAL INSTRUMENT. THE PROCEDURE (ARTERIAL LINE PLACEMENT) WAS NOT SUCCESSFULLY COMPLETED. THE WIRE WAS RETRIEVED SURGICALLY AND THE ARTERY WAS REPAIRED.

  Patient problems: Insufficient Information

  MAUDE report 19821868 ↗
• MalfunctionJul 24, 2024Unraveled Material; Unraveled Material

  AS REPORTED, DURING PLACEMENT OF AN ARTERIAL LINE IN A CRITICAL CARE UNIT, FOUR MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRES, FROM THREE DIFFERENT LOTS, "SPLIT APART" DURING THE SAME PROCEDURE. THIS REPORT CAPTURES ONE SPECIFIC LOT. THE DEVICES FROM THE OTHER UNKNOWN LOTS WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19820900 ↗
• MalfunctionJul 24, 2024Unraveled Material; Unraveled Material

  AS REPORTED, DURING PLACEMENT OF AN ARTERIAL LINE IN A CRITICAL CARE UNIT, FOUR MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRES, FROM THREE DIFFERENT LOTS, "SPLIT APART" DURING THE SAME PROCEDURE. THIS REPORT CAPTURES THE TWO UNKNOWN LOTS. THE DEVICE(S) FROM THE OTHER (KNOWN) LOT WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19820334 ↗
• InjuryOct 6, 2023Break; Break

  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 17886510 ↗
• InjurySep 29, 2023Break; Break

  AS REPORTED, DURING A PROCEDURE TO TREAT MULTILEVEL PERIPHERAL ARTERY DISEASE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S SHEATH SEPARATED. ULTRASOUND-GUIDED ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY, WHICH WAS PATENT AND SUITABLE FOR PERCUTANEOUS ACCESS. AFTER THE MICROPUNCTURE DEVICE WAS PLACED, AN UNSPECIFIED AMPLATZ WIRE WAS USED FOR SHEATH DILATION, SECONDARY TO SCAR TISSUE. THE WIRE WAS ADVANCED TO THE LEVEL OF THE ABDOMINAL AORTA. ALL MANIPULATION OF CATHETERS AND WIRES WAS DONE UNDER FLUOROSCOPIC GUIDANCE. UPON REMOVAL OF THE MICRO SHEATH, ONLY HALF OF THE SHEATH WAS REMOVED. THE SHEATH HAD SEPARATED IN THE MIDDLE OF THE DEVICE, LEAVING HALF OF THE SHEATH IN THE GROIN. AN OPEN CUT-DOWN WAS PERFORMED AND A VERTICAL INCISION WAS MADE OVER THE AMPLATZ WIRE, DISSECTING THE TISSUE DOWN TO THE COMMON FEMORAL ARTERY. A PORTION OF THE SHEATH FRAGMENT WAS FOUND OUTSIDE OF THE VESSEL, AND THE USER WAS ABLE TO REMOVE THE FRAGMENT IN ITS ENTIRETY. THE USER THEN UPSIZED TO AN UNSPECIFIED 6-FRENCH SHEATH, WHICH WAS USED TO COMPLETE THE PROCEDURE. UPON COMPLETION OF THE PROCEDURE, THE PUNCTURE SITE WAS ISOLATED WITHIN THE PROXIMAL LEFT COMMON FEMORAL ARTERY,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844797 ↗
• InjuryDec 8, 2022Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE SEPARATED UPON REMOVAL OF THE DEVICE. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. THE ACCESS SITE WAS NOT CALCIFIED OR SCARRED, AND RESISTANCE WAS NOT REPORTED UPON INSERTION OR REMOVAL OF THE DEVICE. THE DEVICE WAS NOT ADVANCED THROUGH A PREVIOUSLY-PLACED CLOSURE DEVICE. THE WIRE FRAGMENT REMAINS IN THE SUBCUTANEOUS TISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15939169 ↗
• InjuryJan 13, 2022Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING PLACEMENT OF AN ARTERIAL LINE, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET SEPARATED. THE WIRE WAS UNABLE TO BE ADVANCED INTO THE ARTERY. THE NEEDLE WAS EASILY WITHDRAWN, BUT THE WIRE WOULD NOT WITHDRAW AND SUBSEQUENTLY STRETCHED. UPON REMOVAL, THE WIRE WAS NOTED TO BE SEPARATED. AN ULTRASOUND OF THE RADIAL ARTERY WAS SUSPICIOUS FOR A RETAINED DISTAL WIRE. AFTER THE INTENDED PROCEDURE WAS COMPLETED, THE ATTENDING SURGEON EXPLORED THE LEFT RADIAL ARTERY AND REMOVED THE FRAGMENT. THE SEPARATED PORTION OF THE WIRE WAS SENT TO PATHOLOGY. THE PATIENT HAD A POSITIVE LEFT RADIAL PULSE AND GOOD COLLATERAL CIRCULATION AFTER THE WIRE WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13252263 ↗
• MalfunctionSep 2, 2021Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED. THREE DEVICES WERE RETURNED FOR EVALUATION. THE FIRST WAS A CATHETER SHAFT RETURNED WITH NO HUB; THE DEVICE WAS LODGED ON A WIRE GUIDE. THE SECOND WAS RETURNED WITH BOTH INNER AND OUTER CATHETERS WHICH WOULD NOT STAY CONNECTED AND WERE EASY TO PULL APART. THE THIRD DEVICE DISPLAYED AN ELONGATED OUTER CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414485 ↗
• InjuryFeb 16, 2021Material Separation; Material Separation

  UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE TIP OF THE INNER CATHETER WAS FOUND TO BE SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11331626 ↗
• InjurySep 23, 2020Material Separation; Material Separation

  MEDWATCH 3500A RECEIVED 05OCT2020. PER THE MEDWATCH REPORT, THE PATIENT WAS UNDERGOING A PROCEDURE FOR LEFT FEMORAL VEIN THROMBOSIS. AS THE PHYSICIAN EXCHANGED THE 4 FRENCH INTRODUCER TO A 5 FRENCH INTRODUCER SHEATH, THE MICROPUNCTURE WIRE SHEARED OFF. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE FRAGMENT BUT WAS UNABLE TO DO SO. THE RISK OF RETRIEVING THE WIRE OUTWEIGHED THE BENEFIT; THEREFORE, THE SMALL SEGMENT OF WIRE WAS LEFT IN THE SUBCUTANEOUS TISSUE. THE PATIENT WAS MADE AWARE OF THE RETAINED DEVICE. THE ORIGINAL PROCEDURE, WHICH INVOLVED ULTRASOUND-GUIDED ACCESS OF BILATERAL POPLITEAL VEINS, A BILATERAL LOWER EXTREMITY VENOGRAM, MECHANICAL THROMBECTOMY AND INTRAVASCULAR ULTRASOUND OF THE INFERIOR VENA CAVA, LEFT COMMON ILIAC VAIN, LEFT EXTERNAL ILIAC VEIN, LEFT COMMON FEMORAL VEIN, AND LEFT FEMORAL VEIN; AND ANGIOPLASTY AND STENTING OF THE LEFT COMMON ILIAC VEIN, WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10574650 ↗
• MalfunctionAug 19, 2020Separation Problem; Separation Problem

  AS REPORTED, DURING MULTIPLE CATHETERIZATIONS THE WIRE INCLUDED IN MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SETS DETACHED OR BROKE-OFF AT THE TRANSITION POINT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10427144 ↗
• MalfunctionAug 19, 2020Material Frayed; Material Frayed

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10426040 ↗
• MalfunctionAug 11, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10392129 ↗
• InjuryJul 22, 2019Material Frayed; Material Separation; Material Deformation; Material Frayed; Material Separation; Material Deformation

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

  Patient problems: No Code Available

  MAUDE report 8812820 ↗
• InjuryJul 2, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 NOTING THAT THE PATIENT WAS ADMITTED AFTER AN INITIAL FISTULAGRAM FOR MONITORING AND REVISION OF THEIR UPPER ARM AV FISTULA WITH A PATCH ANGIOPLASTY ELEVATION OF FISTULA AND REMOVAL OF FOREIGN BODY ON (B)(6) 2019. THE PATIENT WAS THEN DISCHARGED IN STABLE CONDITION ON (B)(6) 2019 BY THE PHYSICIAN AND SCHEDULED FOR A TWO WEEK FOLLOW UP APPOINTMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8752675 ↗
• MalfunctionJun 19, 2019Material Frayed; Detachment of Device or Device Component; Material Frayed; 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 8713503 ↗
• MalfunctionMay 23, 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 Patient Involvement

  MAUDE report 8636716 ↗
• MalfunctionFeb 13, 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: No Consequences Or Impact To Patient

  MAUDE report 8336776 ↗
• InjuryMay 30, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED NEUROVASCULAR INTERVENTION VIA HEAVILY CALCIFIED ANATOMY, THE HUB ON THE CATHETER PORTION OF THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET "CAME OFF." THIS OCCURRED UPON REMOVAL OF THE CANNULA, AND THE PLACEMENT OF AN 0.035 WIRE IN THE ARTERIOTOMY. THE SEPARATED PIECE OF THE COMPLAINT DEVICE WAS SUCCESSFULLY RETRIEVED WITH FORCEPS. A SECTION OF THE COMPLAINT DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7554004 ↗
• MalfunctionMay 10, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A FEMORAL ENDOVASCULAR ANEURYSM REPAIR, THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET BECAME CAUGHT ON THE PATIENT'S ANATOMY IN THE GROIN REGION. A PIECE OF THE COMPLAINT DEVICE SHEARED OFF INTO THE PATIENT'S ARTERY. REPORTEDLY, THE PIECE REMAINS IN THE PATIENT'S VASCULATURE WITH NO PLANS FOR RETRIEVAL. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECT AS A RESULT OF THIS OCCURRENCE, AND "IS DOING FINE." ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 7502682 ↗
• InjuryFeb 22, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET CATHETER BROKE IN HALF. THE PHYSICIAN WAS ABLE TO RETRIEVE BOTH PIECES OF THE CATHETER AFTER AWHILE OF MANIPULATION. A VASCULAR SURGEON WAS CALLED IN TO SEE THE PATIENT. AFTER HOLDING PRESSURE TO THE GROIN, THE PHYSICIAN WAS ABLE TO CONTINUE WITH THE PROCEDURE. THE PATIENT REMAINED OVERNIGHT FOR OBSERVATION DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 7289102 ↗