Micropuncture G47944Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00827002479449), received between Oct 9, 2014 and Sep 9, 2026 — classified as 16 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (13 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 78 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Material Separation

  Patient problems: Foreign Body In Patient

  MAUDE report 50698280 ↗
• MalfunctionSep 9, 2026Unraveled Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697254 ↗
• MalfunctionAug 11, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50210714 ↗
• InjuryOct 27, 2025Break; Break

  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 23392631 ↗
• MalfunctionSep 11, 2025Break; Break

  AS REPORTED, "FRAGMENTATION" OF A MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23025715 ↗
• MalfunctionJul 29, 2025Unraveled Material; Unraveled Material

  AS REPORTED, DURING IMPLANTATION OF A PORT, A MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S WIRE GUIDE UNRAVELED UPON INSERTION OF THE DEVICE INTO THE PATIENT. THE DEVICE WAS REPORTEDLY USED PROPERLY BY AN EXPERIENCED INTERVENTIONALIST. THE WIRE WAS REMOVED FROM THE PATIENT WITHOUT COMPLICATIONS OR ¿RESIDUE¿. PER THE REPORTER, THERE COULD HAVE BEEN INJURIES TO THE VESSELS WHEN PULLING THE WIRE FROM THE PATIENT; HOWEVER, THERE HAS BEEN NO REPORT OF VESSEL INJURY IN THIS CASE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649033 ↗
• InjuryMay 29, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 11JUN2025. PER THE REPORTER, ULTRASOUND WAS USED TO GUIDE ACCESS. ALTHOUGH THE SUBCOSTAL PERICARDIAL FLUID POCKET WAS IDENTIFIED WITH ULTRASOUND, THE PUNCTURE WAS NOT PERFORMED UNDER DIRECT ULTRASOUND VISUALIZATION ¿AS PER NORMAL PERICARDIOCENTESIS PROCEDURE.¿ HAEMOSEROUS PERICARDIAL FLUID WAS FREELY ASPIRATED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. RESISTANCE WAS NOT ENCOUNTERED UPON INITIAL INSERTION OF THE WIRE THROUGH THE NEEDLE; HOWEVER, RESISTANCE WAS MET AT THE PERICARDIUM, AT WHICH POINT THE USER ATTEMPTED TO REMOVE THE WIRE THROUGH THE NEEDLE, BUT RESISTANCE WAS ENCOUNTERED, AND THE WIRE COULD NOT BE WITHDRAWN. THE TIP OF THE WIRE SUBSEQUENTLY SEPARATED. THE PERICARDIOCENTESIS WAS SUCCESSFULLY COMPLETED USING A DIFFERENT ACCESS KIT VIA AN APICAL APPROACH. DURING A MEETING WITH CARDIOTHORACIC SURGEONS, THE DECISION WAS MADE TO ATTEMPT RETRIEVAL OF THE WIRE FRAGMENT; HOWEVER, THE FRAGMENT WAS NOT FOUND IN THE OPERATING ROOM AND THEREFORE, IT WAS NOT REMOVED. THE USER THEN DECIDED TO LEAVE THE FRAGMENT IN PLACE, AS THERE WAS MINIMAL PERICARDIAL INVOLVEMENT, AND NO OTHER STRUCTURES WERE COMPROMISED. THE P

  Patient problems: Foreign Body In Patient

  MAUDE report 22109892 ↗
• MalfunctionMay 2, 2025Break; Break

  AS REPORTED, DURING AN ANGIOGRAM WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF A DIALYSIS CIRCUIT IN INTERVENTIONAL RADIOLOGY, A MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S OUTER SHEATH BROKE IN HALF UPON REMOVAL FROM THE PATIENT. THE ACCESS SITE WAS REPORTEDLY NORMAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951689 ↗
• MalfunctionSep 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNKNOWN EMERGENCY PROCEDURE, THE PHYSICIAN FOUND A CRACK ON THE TIP OF THE MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S DILATOR. THE PHYSICIAN WAS ATTEMPTING TO PLACE THE DEVICE IN THE "PCI" VIA FEMORAL ARTERY ACCESS AND DID NOT USE A VASCULAR CLOSURE DEVICE. THERE WAS RESISTANCE INSERTING THE DILATOR OVER A GUIDEWIRE. THE PHYSICIAN DISCONTINUED USE AFTER THE CRACKED DILATOR TIP WAS "FOUND". THERE WERE NO KINKS OR SHARP EDGES, AND THE PRODUCT PACKAGING WAS NOT DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME-TYPE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20174784 ↗
• MalfunctionAug 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNSPECIFIED PACEMAKER IMPLANTATION PROCEDURE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S DILATOR TIP WAS CRUSHED/TORN. THE DEVICE PACKAGING WAS NOT DAMAGED. THE DILATOR WAS ADVANCED VIA THE LEFT INTERNAL JUGULAR VEIN ACCESS SITE, HOWEVER, PER THE REPORTER, RESISTANCE WAS FELT AND THE CALCIFIED ANATOMY CRUSHED/TORE THE DILATOR TIP. ANOTHER DEVICE FROM AN UNKNOWN LOT WAS USED TO INSERT THE SHEATH. THE PATIENT HAS RECOVERED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030580 ↗
• MalfunctionAug 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS ORIGINALLY REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE INVOLVING A CALCIFIED LESION BETWEEN THE SHALLOW FEMORAL AND POPLITEAL ARTERIES, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S SHEATH KINKED DURING SEVERAL ATTEMPTS TO INSERT THE DEVICE. THE PACKAGE WAS NOT DAMAGED. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY. THE ANATOMY WAS CALCIFIED. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED. THE KINK WAS NOT SHARP. THE DEVICE WAS REMOVED, AND ANOTHER DEVICE OF THE SAME TYPE (FROM AN UNKNOWN LOT) WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. UPON RETURN AND INITIAL EVALUATION OF THE KINKED DEVICE, THE TIP OF THE SHEATH WAS NOTED TO BE SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990574 ↗
• MalfunctionJun 13, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528731 ↗
• MalfunctionApr 18, 2024Unraveled Material; Device Damaged Prior to Use; Unraveled Material; Device Damaged Prior to Use

  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 19129952 ↗
• MalfunctionApr 5, 2024Deformation Due to Compressive Stress; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  AS ORIGINALLY REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S DILATOR KINKED UPON INSERTION OF THE DEVICE. ANTEGRADE ACCESS WAS OBTAINED IN THE FEMORAL ARTERY TO TARGET A CHRONIC TOTAL OCCLUSION/LESION IN THE SUPERFICIAL FEMORAL ARTERY. AS THE USER ATTEMPTED TO INSERT THE INTRODUCER/DILATOR PAIR INTO THE PATIENT, THE DILATOR REPORTEDLY KINKED, AND THE USER REMOVED THE DEVICE. ANOTHER DEVICE OF THE SAME TYPE (UNKNOWN LOT) WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE PACKAGE WAS NOT DAMAGED. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHEATH/OUTER CANNULA WAS SPLIT AT THE TIP. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19053729 ↗
• MalfunctionMar 28, 2024Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  AS ORIGINALLY REPORTED, DURING A BELOW-THE-KNEE AND SUPERFICIAL FEMORAL ARTERY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S INNER AND OUTER CANNULAS KINKED. THE DEVICE WAS INSERTED INTO THE FEMORAL ARTERY VIA IPSILATERAL ANTEGRADE APPROACH; HOWEVER, THE DEVICE REPORTEDLY KINKED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND ANOTHER MPIS SET WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE PACKAGE WAS NOT DAMAGED. 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. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE TIP OF THE OUTER CANNULA/CATHETER WAS SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000879 ↗
• MalfunctionMar 13, 2024Stretched; Stretched

  AS ORIGINALLY REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE SHALLOW FEMORAL ARTERY (SFA), A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S COAXIAL SHEATH KINKED. THE LESION WAS CALCIFIED, HOWEVER, IT IS UNKNOWN TO WHAT EXTENT. THE SHEATH WAS INSERTED IPSILATERALLY WITH AN ANTEGRADE APPROACH VIA THE FEMORAL ARTERY "SEVERAL TIMES", HOWEVER, THE SHEATH WAS UNABLE TO ADVANCE DUE TO A KINK. THE SHEATH WAS REMOVED AND STRETCHING WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STIFF MICROPUNCTURE SET. THERE HAVE BEEN NO ADVERSE EFFECTS REPORTED DUE TO THIS OCCURRENCE. INFORMATION WAS RECEIVED 07MAR2024 AND 12MAR2024 STATING THAT THE SHEATH WAS STRETCHED UPON REMOVAL FROM THE PATIENT AND AN ANTEGRADE APPROACH WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894103 ↗
• InjuryOct 9, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 12OCT2023. THE PROCEDURE INVOLVED CORONARY ANGIOGRAPHY. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY WITH THE COMPLAINT DEVICE, USING FLUOROSCOPY, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE. THE WIRE WAS REMOVED THROUGH THE ENTRY NEEDLE. THE ANATOMY WAS MODERATELY CALCIFIED. THE DEVICE WAS NOT ADVANCED OR REMOVED THROUGH A PREVIOUSLY PLACED CLOSURE DEVICE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OF THE DEVICE; HOWEVER, RESISTANCE WAS ENCOUNTERED DURING REMOVAL, AT WHICH POINT THE OUTER SHEATH/CANNULA SEPARATED. THE PROCEDURE WAS ABANDONED, AND THE SHEATH/CANNULA FRAGMENT REMAINS IN THE PATIENT'S FEMORAL ARTERY. VASCULAR SURGEONS WERE CONSULTED, WHO PLAN TO REMOVE THE FRAGMENT WITH A SNARE. IF THAT FAILS, AN OPEN RETRIEVAL WILL BE ATTEMPTED. THE PATIENT EXPERIENCED AN INCREASED LENGTH OF HOSPITAL STAY AND IS NOW AWAITING ANOTHER PROCEDURE OR SURGERY TO REMOVE THE FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17895588 ↗
• MalfunctionJun 7, 2023Packaging Problem; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED 16JUN2023 FROM THE CUSTOMER, NOTING THAT THE PACKAGE SEAL WAS INTACT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE AT COOK, THE PACKAGE HAD BEEN OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079161 ↗
• MalfunctionMay 17, 2023Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE COMMON FEMORAL ARTERY, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S OUTER SHEATH SEPARATED. RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE DEVICE INTO THE PATIENT. THE DEVICE WAS REMOVED SAFELY AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16949910 ↗
• MalfunctionApr 11, 2023Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16715845 ↗
• MalfunctionMar 7, 2023Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16494315 ↗
• MalfunctionFeb 21, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 16410124 ↗
• MalfunctionDec 16, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S DILATOR SPLIT. THE INTRODUCER/DILATOR WAS DIFFICULT TO ADVANCE INTO THE FEMORAL ARTERY AND RESISTANCE WAS REPORTED. THE DILATOR TIP WAS NOTED TO BE SPLIT/ROUGH/FRAYED/UNSMOOTH; THEREFORE, THE USER DISCONTINUED USE OF THE DEVICE AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE PACKAGE WAS NOT DAMAGED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998570 ↗
• InjuryDec 1, 2022Break; Break

  AS REPORTED, DURING AN ELECTROPHYSIOLOGY ABLATION PROCEDURE, A WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET SEPARATED. THE ANATOMY WAS REPORTEDLY NORMAL. PER THE REPORTER, NOTHING UNUSUAL OCCURRED WHEN THE DEVICE WAS INSERTED INTO THE INTERNAL JUGULAR ARTERY; HOWEVER, TENSION WAS ENCOUNTERED, AND THE WIRE WAS PULLED OUT THROUGH THE ENTRY NEEDLE AND REPLACED WITH A NEW WIRE. THE USER DID NOT REALIZE THAT PART OF THE WIRE SEPARATED AT THAT TIME. THE PATIENT EXPERIENCED RIGHT UPPER CHEST AND NECK PAIN AND WAS DIRECTED TO THE EMERGENCY ROOM SEVERAL DAYS LATER BY THE PHYSICIAN. A CT SCAN NOTED AN EXTRA-LUMINAL LINEAR METALLIC OBJECT, HAVING THE APPEARANCE OF A FRACTURED WIRE, WITHIN THE SOFT TISSUES OF THE BASE OF THE NECK, EXTENDING INTO THE RIGHT MEDIASTINAL REGION. A PROCEDURE TO EXTRACT THE FOREIGN BODY WAS SCHEDULED AND PERFORMED ON (B)(6) 2022 AT A DIFFERENT HOSPITAL.

  Patient problems: Chest Pain; Foreign Body In Patient; Neck Pain

  MAUDE report 15896058 ↗
• MalfunctionJul 6, 2022Material Frayed; Material Deformation; Material Frayed; Material Deformation

  AS REPORTED, PRIOR TO PATIENT CONTACT DURING A PROCEDURE INVOLVING PACEMAKER IMPLANTATION VIA ACCESS IN THE LEFT SUBCLAVIAN VEIN, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S SHEATH WAS NOTED TO BE FRAYED AT THE TIP. ANOTHER DEVICE OF THE SAME TYPE, FROM THE SAME LOT, WAS USED TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14929069 ↗