Micropuncture G43872Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002438729), received between Dec 7, 2016 and Apr 17, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2025Break; Break

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, DURING WHICH A MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS USED, THE WIRE ¿SEPARATED AT THE HUB¿ AND PER THE REPORTER, IS BELIEVED TO RESULT IN THE SHEATH ¿BEING DETACHED IN THE LEG¿. FLUOROSCOPY WAS UNABLE TO IDENTIFY A SEPARATED FRAGMENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL EXPLORATION; HOWEVER, NO FOREIGN BODIES WERE IDENTIFIED. THERE WAS NO EVIDENCE OF A FOREIGN BODY WITHIN THE PATIENT. A CT WITHOUT CONTRAST OF THE RIGHT LEG AND AN ULTRASOUND OF THE ARTERIES IN THE LOWER EXTREMITIES WERE ALSO PERFORMED ON THE DAY OF THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CLARIFY DETAILS OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857393 ↗
• MalfunctionAug 9, 2022Unraveled Material; Unraveled Material

  AS ORIGINALLY REPORTED TO COOK, PRIOR TO USE DURING AN UNSPECIFIED PROCEDURE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S WIRE WAS NOTED TO BE BENT. THE DEVICE WAS NOT USED. UPON RETURN AND EVALUATION OF THE DEVICE, THE WIRE WAS NOTED TO BE UNRAVELED, AND THE SOLDER WAS BROKEN IN MULTIPLE LOCATIONS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE HAS BEEN NO REPORT OF ANY ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190723 ↗
• InjuryFeb 12, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 19FEB2021 VIA A MEDWATCH 3500A. DURING PLACEMENT OF A PORT-A-CATH IN INTERVENTIONAL RADIOLOGY, THE LEFT INTERNAL JUGULAR VEIN WAS VISUALIZED UNDER FLUOROSCOPY WITH IMAGE DOCUMENTATION OF NEEDLE ENTRY INTO THE LEFT INTERNAL JUGULAR. AN ATTEMPT TO ADVANCE THE GUIDEWIRE CENTRALLY WAS UNSUCCESSFUL AND IN REMOVING THE NEEDLE AND GUIDEWIRE, THE GUIDEWIRE WAS FRACTURED, AND A SEGMENT WAS LODGED IN THE SUBCUTANEOUS TISSUE. ATTEMPTS AT REMOVAL WERE UNSUCCESSFUL AND SURGERY WAS CALLED FOR ASSISTANCE. THE SURGEON WAS ABLE TO EXTEND THE INCISION BY 1-CENTIMETER TO ALLOW FOR DISSECTION AND WAS ABLE TO GRASP THE TISSUE IN WHICH THE GUIDEWIRE WAS EMBEDDED AND REMOVE THE FRAGMENT. THE RADIOLOGIST WAS THEN ABLE TO COMPLETE PORT-A-CATH PLACEMENT WITHOUT FURTHER INCIDENT.

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

  MAUDE report 11323179 ↗
• MalfunctionApr 6, 2020Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION RECEIVED 02APR2020. THE EVENT INVOLVED A PERCUTANEOUS NEPHROSTOMY TUBE. THE WIRE DID NOT ENTER THE PATIENT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9930113 ↗
• MalfunctionApr 6, 2020Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION RECEIVED 02APR2020. THE EVENT INVOLVED A PERCUTANEOUS NEPHROSTOMY TUBE. THE WIRE DID NOT ENTER THE PATIENT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9929870 ↗
• MalfunctionJul 24, 2017Unraveled Material

  THE WIRE UNRAVELED UPON REMOVAL FROM THE NEEDLE. A NEW DEVICE WAS OPENED AND 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 Known Impact Or Consequence To Patient

  MAUDE report 6735820 ↗
• MalfunctionJul 17, 2017Unraveled Material

  WHEN THEY WERE REMOVING THE INSIDE INTRODUCER AND WIRE FROM THE PATIENT, THE WIRE UNRAVELED. THE CUSTOMER CONFIRMED THAT THEY HAD REMOVED THE NEEDLE BEFORE REMOVING THE WIRE AND INTRODUCER. 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 6717297 ↗
• InjuryDec 7, 2016Material Frayed; Material Frayed

  IT WAS REPORTED THAT A MICRO-PUNCTURE KIT WAS USED FOR ACCESSING THE RIGHT FEMORAL ARTERY UNDER ULTRASOUND GUIDANCE. IT WAS FURTHER REPORTED THE NEEDLE PUNCTURED THE ARTERY AND THE WIRE WAS THREADED INTO THE ARTERY. THE WIRE WAS EXAMINED UNDER FLOURO AND REVEALED THE WIRE HAD COILED UPON ITSELF AND NEEDED TO BE EXCHANGED FOR A NEW WIRE. THE PHYSICIAN HAD DIFFICULTY REMOVING THE WIRE AND HAD TO FIRST REMOVE THE ACCESS NEEDLE. UPON REMOVAL OF THE WIRE, A VISUAL INSPECTION SHOWED THE WIRE FRAYED. FLURO REVEALED REMNANTS OF THE WIRE IN THE PATIENT ANATOMY. THE ACCESS NEEDLE WAS VISUALLY INSPECTED AND REPORTEDLY ¿APPEARED APPROPRIATE." THE ATTENDING PHYSICIAN CONSULTED WITH TWO VASCULAR SURGEONS AND THE DETERMINATION WAS MADE TO LEAVE THE FRAGMENTS IN THE PATIENTS ANATOMY, THE PATIENT WAS INFORMED OF THE DECISION. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6150866 ↗