Micropuncture G48006Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002480063), received between Jul 11, 2014 and May 21, 2025 — classified as 13 injuries, 3 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Unraveled Material; Unraveled Material

  AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE UNRAVELED. ULTRASOUND-GUIDED ACCESS WAS OBTAINED. THE PHYSICIAN INSERTED THE MICROPUNCTURE WIRE THROUGH THE MICROPUNCTURE SHEATH AND INTO THE POPLITEAL ARTERY. RESISTANCE WAS ENCOUNTERED AS THE WIRE WAS PASSED THROUGH AN UNKNOWN STENT IN THE POPLITEAL ARTERY, AND THE TIP OF THE WIRE REPORTEDLY ¿SHEARED¿; HOWEVER, IT WAS REMOVED IN ¿ONE UNIT¿. THE WIRE WAS PULLED BACK THROUGH THE SHEATH. PER THE REPORTER, IT IS POSSIBLE THAT THE WIRE MAY HAVE GONE BEHIND THE STENT, CAUSING THE WIRE DAMAGE. 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 22060416 ↗
• InjurySep 29, 2023Break; Break

  AS REPORTED, DURING AN ANGIOGRAM OF THE BILATERAL LOWER EXTREMITIES, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S SHEATH SEPARATED IN HALF INSIDE THE PATIENT. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF THE SEPARATED DEVICE FRAGMENT. THE PATIENT IS REPORTEDLY "OK" AND RECOVERING. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17843859 ↗
• MalfunctionJul 21, 2023Break; Break

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE SEPARATED. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY, USING THE MICROPUNCTURE NEEDLE. THE WIRE WAS ADVANCED, THE NEEDLE WAS REMOVED, AND THE MICROPUNCTURE SHEATH WAS INSERTED. AS THE USER ATTEMPTED TO REMOVE THE WIRE FROM THE SHEATH, THE WIRE BROKE, LEAVING A PORTION OF THE WIRE IN THE ARTERY. AN INTERVENTIONALIST WAS CONSULTED, AND THE WIRE FRAGMENT WAS SUCCESSFULLY REMOVED INTACT, USING SNARES AND FLUOROSCOPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373220 ↗
• InjuryJul 7, 2022Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING A VENOGRAM VIA ACCESS IN THE POPLITEAL VEIN, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET¿S WIRE SEPARATED. THE WIRE WAS INSERTED INTO THE NEEDLE AND MANIPULATED TO FURTHER ADVANCE INTO THE VESSEL. THE WIRE TIP "BUNCHED UP", AND THE USER REMOVED THE NEEDLE AND WIRE TOGETHER, AT WHICH POINT IT WAS DISCOVERED THAT A SMALL PORTION OF THE DISTAL WIRE TIP HAD UNRAVELED AND SEPARATED. THE SEPARATED PORTION OF THE WIRE REMAINS IN THE SOFT TISSUES OF THE PATIENT¿S RIGHT THIGH. CURRENTLY, THE PHYSICIAN DOES NOT PLAN TO REMOVE THE FRAGMENT FROM THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED AND THERE WERE NO FURTHER COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 14945053 ↗
• MalfunctionJul 7, 2021Contamination; Contamination

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128028 ↗
• InjuryJun 8, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11956770 ↗
• InjuryOct 14, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10680612 ↗
• InjuryOct 1, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 10612947 ↗
• InjuryAug 25, 2020Material Separation; Material Separation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A WIRE INCLUDED IN THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET SHEARED OFF IN A PATIENT AND REMAINS IN THE EXTRA-VASCULAR TISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 10449004 ↗
• InjuryMar 24, 2020Material Separation; Unraveled Material; Material Split, Cut or Torn; Material Separation; Unraveled Material; 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: Foreign Body In Patient

  MAUDE report 9873502 ↗
• InjuryOct 7, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION: THE EVENT WAS REPORTED TO THE FDA BY THE USER FACILITY. MEDWATCH MW5089895 WAS RECEIVED BY THE MANUFACTURER 07OCT2019. THERE ARE NO ADDITIONAL DETAILS IN THE MEDWATCH REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9161318 ↗
• InjuryDec 29, 2017Material Separation; Material Separation

  IT HAS BEEN REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A PORTION OF THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DEVICE SEPARATED INSIDE THE PATIENT. THE SEPARATED PORTION WAS SUCCESSFULLY RETRIEVED WITH A SNARE. NO UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7155454 ↗
• InjuryMay 26, 2017Break; Break

  IT WAS REPORTED THAT DURING A LEFT LOWER EXTREMITY CUTTING BALLOON ANGIOPLASTY AND STENT ANGIOGRAM AND INTERPRETATION, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET WAS USED TO GAIN ACCESS TO THE PATIENT. THE SURGEON NOTICED ON FLUOROSCOPY THAT THE WIRE HAD BROKEN; THE SURGEON WAS ABLE TO REMOVE THE WIRE. IT WAS VERIFIED UNDER FLUOROSCOPY THAT ALL THE PIECES WERE REMOVED. THERE WAS REPORTEDLY NO HARM TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6593828 ↗
• InjuryMay 3, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A MEDIPORT INSERTION USING A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET, WHILE ACCESSING THE SUBCLAVIAN VEIN, THE USER ENCOUNTERED DIFFICULTY ADVANCING THROUGH THE VESSEL AND THE WIRE WAS PULLED BACK. UPON PULLING BACK ON THE WIRE, THE WIRE BEGAN TO UNRAVEL, THEN SHEARED OFF. THE SHEARED PORTION OF THE WIRE WAS REMOVED FROM SUBCUTANEOUS TISSUE WITH A SLIGHT CUT DOWN OF THE ACCESS SITE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6541522 ↗
• InjuryAug 6, 2014Tip breakage

  EVENT DESCRIPTION FROM MEDSUN REPORT INDICATED THAT ON (B)(6) 2014 A (B)(6) PT WITH COPD, CORONARY HEART DISEASE, DIABETES, HEPATIC/RENAL DYSFUNCTION, HYPERTENSION, AND WAS MORBIDLY OBESE HAD AN ANGIOPLASTY AND STENTING OF THE RIGHT EXTERNAL ILIAC ARTERY AND THE RIGHT FEMORAL ARTERY WAS ENTERED WITH MICROPUNCTURE NEEDLE ON FIRST ATTEMPT. THE MICROWIRE FIRST PASSED, WENT UP INTO THE RENAL BYPASS AREA, REPOSITIONED, THEN INTO THE EXTERNAL ILIAC ARTERY UNDER FLUOROSCOPY; HOWEVER, COULD NOT PASS BEYOND THE PROXIMAL PORTION OF THE RIGHT EXTERNAL ILIAC ARTERY, DESPITE MULTIPLE ATTEMPTS. WITH THAT BEING THE CASE, THE PHYSICIAN THEN INSERTED A MICROSHEATH AND DID A HAND INJECTION, WHICH SHOWED NO DEFECT IN THE AP VIEW. THE PHYSICIAN DID SEVERAL SMALL OBLIQUES, AGAIN COULD NOT SEE ANY ISSUE. THE PHYSICIAN; THEREFORE, PLANNED TO REMOVE THE MICROWIRE AND TRY TO PASS A J-TIP AND IN THE PROCESS OF REMOVING THE MICROWIRE, IT SNAGGED ON WHAT APPEARED TO A PLAGUE IN THE COMMON FEMORAL ARTERY. EVEN WITH REMOVAL OF THE MICROSHEATH, COULD NOT RETRIEVE THE WIRE AND THEREFORE HAD TO PULL THIS BACK. IT DID GO BUT THE TIP DID NOT APPEAR TO BE INTACT AND FLUOROSCOPY SHOWED THAT THERE WAS PROBABLY A CM AND

  Patient problems: Foreign body, removal of

  MAUDE report 4008500 ↗
• InjuryJul 11, 2014Wire(s), breakage of

  (B)(4) INDICATED THAT DURING VENOUS THROMBOSIS EXTRACTION THROUGH RIGHT POPLITEAL, THE WIRE GOT INTO A CLOT AND STARTED TO UNRAVEL AND SHEARED. PROCEDURE COMPLETED AND WIRE RETRIEVED WITH A MICROSCOPIC PIECE REMAINING IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED (B)(4) 2014 - NO ADDITIONAL PROCEDURE SCHEDULED OR PERFORMED. NOT SURE WHERE IN THE BODY THE DEVICE PORTION IS.

  Patient problems: Nonresorbable materials, unretrieved in body

  MAUDE report 3964099 ↗