Micropuncture G48007Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002480070), received between Jul 18, 2017 and Jan 15, 2024 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2024Break; Unraveled Material; Break; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 05FEB2024. THE ACCESS SITE WAS NOT SCARRED OR CALCIFIED. ACCESS WAS OBTAINED USING ULTRASOUND GUIDANCE. RESISTANCE WAS ENCOUNTERED UPON INSERTION AND/OR REMOVAL OF THE DEVICE COMPONENTS. PER THE PHYSICIAN, THE WIRE WOULD NOT PULL OUT THROUGH THE NEEDLE AFTER IT WAS ADVANCED THROUGH THE NEEDLE. THE NEEDLE WAS REMOVED, BUT THE WIRE WOULD NOT COME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18511857 ↗
• InjuryAug 23, 2022Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING THE RIGHT FEMORAL ARTERY, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE UNRAVELED AND SEPARATED UPON INSERTION, LEAVING A SMALL FRAGMENT IN THE PATIENT. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY AND THE ACCESS SITE WAS REPORTEDLY CALCIFIED. RESISTANCE WAS ENCOUNTERED UPON BOTH INSERTION AND REMOVAL OF THE WIRE, WHICH WAS MANIPULATED AND/OR REMOVED THROUGH THE ENTRY NEEDLE. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR REMOVAL OF THE WIRE FRAGMENT; HOWEVER, THE DECISION WAS MADE NOT TO REMOVE IT. THE FRAGMENT REPORTEDLY REMAINS IN THE LEFT GROIN, EITHER EXTRAVASCULAR TO THE FEMORAL ARTERY, OR SLIGHTLY INTRAVASCULAR. 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 15275358 ↗
• InjuryJun 24, 2022Break; Break

  AS REPORTED VIA A MEDWATCH REPORT, DURING AN UNKNOWN PROCEDURE, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET SEPARATED DURING THE PROCEDURE, CAUSING THE PATIENT TO UNDERGO AN ADDITIONAL SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14806715 ↗
• MalfunctionOct 11, 2021Unraveled Material; Unraveled Material

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

  Patient problems: Insufficient Information

  MAUDE report 12605995 ↗
• InjuryAug 23, 2021Material Separation; Material Separation

  AS REPORTED VIA A MEDWATCH REPORT, DURING AN ANGIOPLASTY OF THE LEFT LEG, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE GUIDE SEPARATED UPON REMOVAL FROM THE LEFT GROIN PUNCTURE SITE. A PORTION OF THE DEVICE WAS RETAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12352911 ↗
• MalfunctionMay 20, 2021Unsealed Device Packaging; Unsealed Device Packaging

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854802 ↗
• MalfunctionMay 20, 2021Unsealed Device Packaging; Unsealed Device Packaging

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854756 ↗
• InjuryMay 5, 2021Material Separation; Material Separation

  AS REPORTED VIA A MEDWATCH REPORT, WHILE OBTAINING VASCULAR ACCESS DURING AN UNSPECIFIED PROCEDURE, THE TIP OF A WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET SEPARATED IN THE RIGHT COMMON FEMORAL ARTERY. NO ACCESS WAS OBTAINED ON THE RIGHT SIDE. A CARDIOVASCULAR SURGEON WAS CALLED TO PERFORM A SELECTIVE CANNULATION OF THE RIGHT PROXIMAL EXTERNAL ILIAC ARTERY FROM A LEFT FEMORAL APPROACH. A SNARE WAS USED TO REMOVE "THE ENTIRE SYSTEM" AND CONSTANT PRESSURE WAS MAINTAINED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 11777105 ↗
• InjuryJan 25, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11225404 ↗
• InjuryFeb 3, 2020Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A COOK MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET GUIDE FRAYED AND SPLIT. THE GUIDE WIRE WAS REPORTEDLY DIFFICULT TO ADVANCE OR RETRACT DURING PLACEMENT, THEREFORE, THE PHYSICIAN PULLED THE INTRODUCER FROM THE WIRE. AT THAT POINT, THE GUIDE WAS NOTED TO BE FRAYED AND SPLIT LONGITUDINALLY. THE PHYSICIAN CLAMPED THE WIRE AND OBTAINED A VASCULAR CONSULT. THE PATIENT UNDERWENT AN EMERGENT SURGICAL PROCEDURE TO REMOVE THE DEVICE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 9660125 ↗
• InjuryNov 20, 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 9349610 ↗
• InjuryOct 10, 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 9176866 ↗
• MalfunctionJul 30, 2019Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THE MICROPUNCTURE SET WAS BEING USED AT THE START OF THE PROCEDURE WHEN IT BEGAN TO UNCOIL AND WAS UNABLE TO BE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842348 ↗
• InjuryJul 12, 2019Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING AN AORTOGRAM AND BILATERAL SELECTIVE ANGIOGRAM WITH POSSIBLE INTERVENTION ON (B)(6) ''209'', INVOLVING A (B)(6) YEAR-OLD FEMALE PATIENT, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET INTRODUCER/INNER CANNULA "STRIPPED". THE PATIENT, WEIGHING (B)(6) KILOGRAMS, HAD A MEDICAL HISTORY OF ISCHEMIC CARDIOMYOPATHY, PERIPHERAL ARTERY DISEASE, CAROTID ARTERY DISEASE, BENIGN HYPERTENSION, TYPE 2 DIABETES MELLITUS, SYMPTOMATIC BRADYCARDIA WITH PERMANENT PACEMAKER (PPM), AND A FORMER HISTORY OF SMOKING. SUCCESSFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE LEFT EXTERNAL ILIAC ARTERY WAS PERFORMED. AS THE USER ATTEMPTED TO ACCESS THE RIGHT COMMON FEMORAL ARTERY WITH THE COMPLAINT DEVICE IN ORDER TO PLACE A LARGER DIAMETER WIRE, THE COATING OF THE INTRODUCER REPORTEDLY BECAME STRIPPED. THE ACCESS SITE WAS REPORTED TO BE CALCIFIED. THE PATIENT WAS REFERRED FOR VASCULAR SURGERY FOR BILATERAL COMMON FEMORAL ENDARTERECTOMIES AND SUCCESSFUL REMOVAL OF THE INTRODUCER IN THE RIGHT COMMON FEMORAL ARTERY. THE PATIENT REPORTEDLY EXPERIENCED "SOME" DELIRIUM AND CONFUSION IN THE INTENSIVE CARE UNIT AS WELL AS DECREASED URINARY OUTPUT THAT WAS RESPONSIVE TO ADMINISTRATION

  Patient problems: No Code Available

  MAUDE report 8784964 ↗
• MalfunctionJul 3, 2019Peeled/Delaminated; Peeled/Delaminated

  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 8757797 ↗
• MalfunctionJul 13, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE INNER LINING OF THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET PEELED OFF. ANOTHER DEVICE WAS UTILIZED TO SUCCESSFULLY 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 7687521 ↗
• MalfunctionAug 21, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET WAS USED IN A RIGHT LOWER EXTREMITY ANGIOGRAM. IT WAS REPORTED, WHEN THE PHYSICIAN TRIED TO INSERT THE WIRE THROUGH THE "DILATOR," IT WOULD NOT ADVANCE AND A "PIECE OF METAL" WAS NOTED TO BE STICKING OUT OF THE HUB OF THE ALLEGED DILATOR. THE PHYSICIAN WAS ABLE TO PULL THE METAL OUT OF THE DILATOR AND IT APPEARED TO BE THE STIFFENED PART OF THE INNER DILATOR. 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. ADDITIONAL QUESTIONS AND PRODUCT CLARIFICATION HAVE BEEN REQUESTED. UPON RECEIVING NEW INFORMATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6806927 ↗
• MalfunctionJul 26, 2017Fitting Problem; Torn Material

  IT WAS REPORTED THAT WHEN INTRODUCING THE DEVICE INTO THE PATIENT, THE DILATOR WOULD NOT FIT IN THE SHEATH. THE USER REMOVED THE DEVICE AND USED ANOTHER TO CONTINUE 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. DURING INVESTIGATION, VISUAL EXAMINATION NOTED THE DISTAL END OF THE SHEATH WAS TORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6743393 ↗
• MalfunctionJul 18, 2017Material Separation

  IT WAS REPORTED THE TIP OF THE WIRE GUIDE SEPARATED UPON REMOVAL FROM THE PATIENT. THE TIP WAS STILL INTACT AND THEY WERE ABLE TO REMOVE THE WIRE GUIDE WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6723514 ↗