Micropuncture G48008Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002480087), received between Nov 30, 2017 and Jul 8, 2025 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Unraveled Material; Unraveled Material

  AS REPORTED, DURING A CORONARY ARTERY BYPASS GRAFT (CABG) WITH A "REDO" OF THE STERNOTOMY, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE GUIDE "SPLIT IN HALF OR FRAYED" WHILE PLACING A FEMORAL CENTRAL LINE. THE DEVICE, WHICH WAS REPORTEDLY IN PLACE FOR TEN-TO-FIFTEEN MINUTES, WAS REPLACED. THE PATIENT WAS NOT INJURED. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE WIRE'S COIL WAS SEPARATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435731 ↗
• MalfunctionApr 30, 2025Unraveled Material; Unraveled Material

  AS REPORTED, DURING A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET¿S WIRE GUIDE ¿SHREDDED¿ UPON REMOVAL FROM THE DILATOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE DEVICE WAS NO LONGER NEEDED. THE PATIENT, WHO WAS NOT INJURED, DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, PER THE CUSTOMER, ADDITIONAL INFORMATION WILL NOT BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933356 ↗
• MalfunctionJan 13, 2025Unraveled Material; Unraveled Material

  AS REPORTED, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE UNRAVELED DURING AN UNKNOWN PROCEDURE. ULTRASOUND-GUIDED ACCESS WAS OBTAINED, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. THE ACCESS SITE (GROIN) WAS NOT SCARRED OR CALCIFIED. THE WIRE REPORTEDLY BECAME STUCK IN THE ACCESS NEEDLE. THE USER THEN ATTEMPTED TO REMOVE THE WIRE BACKWARDS THROUGH THE NEEDLE; HOWEVER, THE WIRE COULD NOT BE REMOVED. THE WIRE AND NEEDLE WERE THEN REMOVED TOGETHER, LOSING ACCESS. PER THE REPORTER, THE FLOPPY TIP OF THE WIRE WAS "STRETCHED OUT". THE PROCEDURE WAS COMPLETED AFTER OPENING ANOTHER KIT. 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 21139414 ↗
• MalfunctionDec 31, 2024Stretched; Stretched

  AS REPORTED, DURING AN ANGIOGRAM, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S INNER CANNULA/DILATOR STRETCHED. ULTRASOUND-GUIDED ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. AFTER BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, THE WIRE WAS PLACED, AND THE NEEDLE WAS REMOVED. THE USER THEN ADVANCED ONLY THE INNER CANNULA/DILATOR OVER THE WIRE. RESISTANCE WAS ENCOUNTERED DURING INSERTION AND/OR REMOVAL OF THE DEVICE, AS THE GROIN WAS SCARRED, AND PER THE REPORTER, ACCESS WAS DIFFICULT. REPORTEDLY, THE INNER CANNULA/DILATOR STRETCHED UPON REMOVAL AS THE USER ATTEMPTED TO "WALK" THE INNER CANNULA OFF OF THE MICROPUNCTURE WIRE, BUT IT DID NOT TEAR. ALTHOUGH REMOVAL WAS REPORTEDLY DIFFICULT, THE WIRE AND INNER CANNULA/DILATOR WERE REMOVED FROM THE PATIENT AS A UNIT AND INTACT. THE COMPLAINT DEVICE WAS NOT ADVANCED OR REMOVED THROUGH A PREVIOUSLY PLACED VASCULAR CLOSURE DEVICE. THE PROCEDURE WAS COMPLETED. 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 21048289 ↗
• MalfunctionDec 26, 2024Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING A RIGHT HEART CATHETERIZATION, A MICROPUNCTURE TRADITIONLESS STIFFENED CANNULA ACCESS SET¿S INTRODUCER BROKE OFF IN THE PATIENT. RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE DEVICE INTO THE JUGULAR VEIN, AS THE ACCESS SITE HAD ¿A LOT¿ OF SCAR TISSUE FROM MULTIPLE PRIOR PROCEDURES. DURING INSERTION OF THE CANNULA, IT SEPARATED APPROXIMATELY ONE INCH BELOW THE HUB. THE HUB WAS REPORTEDLY INTACT. A SNARE WAS USED TO REMOVE THE SEPARATED FRAGMENT, AND ANOTHER MICROPUNCTURE SET 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 OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019627 ↗
• MalfunctionJun 19, 2024Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 25JUN2024. ACCESS WAS GAINED USING ULTRASOUND GUIDANCE AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDED, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. DURING INSERTION THROUGH THE CALCIFIED FEMORAL ARTERY, PART OF THE WIRE SHEERED OFF INSIDE THE PATIENT. SLIGHT RESISTANCE WAS FELT DURING REMOVAL OF THE WIRE. THE "SHEERED-OFF" PORTION OF THE WIRE WAS REMOVED WITH AN UNSPECIFIED SNARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS BODY AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565741 ↗
• MalfunctionOct 30, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S UNOPENED PACKAGE WAS REPORTEDLY PUNCTURED AND UNSTERILE. THE DEVICE WAS NOT USED, AND THE PACKAGE WAS DISCARDED BY THE CUSTOMER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18031012 ↗
• MalfunctionSep 6, 2023Unraveled 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 17692003 ↗
• MalfunctionMay 12, 2021Unraveled 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 11812835 ↗
• MalfunctionMar 25, 2021Unraveled 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 11568754 ↗
• InjuryDec 10, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material

  AS REPORTED, WHILE USING A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET, THE ACCESS WIRE SHREDDED. IT DID NOT BREAK, BUT IT DID UNCOIL AND BECOME ELONGATED. A SMALL PORTION OF THE TIP REMAINED INSIDE OF THE PATIENT. THE ACCESS SITE WAS NOTED TO BE VERY CALCIFIED. AND THERE WAS RESISTANCE DURING INSERTION/ REMOVAL OF THE DEVICE. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10983508 ↗
• InjuryJan 16, 2020Material Separation; Material Separation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET WIRE SHEARED OFF AND WAS LEFT IN THE PATIENT'S TISSUE. RESISTANCE WAS REPORTED AND THE NEEDLE AND WIRE WERE REMOVED, AT WHICH TIME THE WIRE SEPARATED. 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 9595692 ↗
• MalfunctionApr 25, 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 8549789 ↗
• InjuryAug 30, 2018Material Separation; Material Separation

  IT WAS REPORTED, THE METAL CANNULA OF THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET SEPARATED FROM THE DILATOR. THIS SEPARATION OCCURRED DURING A LEG ANGIOPLASTY PROCEDURE. WHILE ATTEMPTING TO GAIN ACCESS TO THE DISTAL SUPERFICIAL FEMORAL ARTERY, WHICH WAS REPORTED TO BE A CALCIFIED VESSEL, THE MICROPUNCTURE NEEDLE WAS INSERTED ALONG WITH THE MANDRILL WIRE. UPON TRYING TO REMOVE THE DILATOR, THE INNER METAL CANNULA WAS REMOVED, BUT THE WHITE PORTION OF THE DILATOR REMAINED INSIDE THE PATIENT. AT THAT TIME THE WHITE DILATOR "LOST ITS STIFFNESS". THE PHYSICIAN THEN USED A .018 WIRE INTO THE WHITE DILATOR AND REMOVED IT. 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 Code Available

  MAUDE report 7834483 ↗
• MalfunctionMay 17, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A TUNNELED CATHETER PLACEMENT, THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET BECAME CAUGHT ON THE NEEDLE DURING RETRACTION AND UNRAVELED. ALL OF THE COMPLAINT DEVICE WAS ABLE TO BE RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW WIRE. THE PATIENT DID NOT REQUIRE ADDITIONAL INTERVENTION. 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 7523064 ↗
• InjuryJan 25, 2018Material Separation; Unraveled Material; Failure to Advance; Material Separation; Unraveled Material; Failure to Advance

  PER USER FACILITY VOLUNTARY MEDWATCH (B)(4): "CARDIOLOGIST WAS CALLED IN DURING THE MIDDLE OF THE NIGHT TO PLACE A TEMPORARY PACER FOR PATIENT WHO WAS EXPERIENCING SYMPTOMATIC BRADYCARDIA. NEEDLE INSERTED INTO RIGHT INTERNAL JUGULAR VEIN WITH DRAW BACK OF BLOOD; WENT TO ADVANCE THE WIRE; WIRE WOULD NOT ADVANCE; WENT TO REMOVE THE WIRE AND THERE WAS RESISTANCE WHEN TRYING TO REMOVE THE WIRE; REMOVED WIRE AND NEEDLE; WIRE WAS UNRAVELED; GAINED ACCESS AGAIN WITH MICROPUNCTURE NEEDLE; NEW WIRE ADVANCED; WHILE ADVANCING THE TEMPORARY CATHETER, NOTICED SOMETHING ON THE X-RAY BUT UNSURE IF IT WAS SOMETHING NEW OR SOMETHING FROM A PAST PROCEDURE; AFTER CATHETER WAS PLACED AND THE QUESTIONABLE OBJECT LOOKED AT. PROCEDURE FINISHED WITH NEW WIRE. DOCTOR BELIEVES THE RADIOPAQUE, 'SOFT CLOTH PART' BROKE OFF FROM THE ORIGINAL WIRE. FLUORO WAS OBTAINED AND THE FRAGMENT WAS DETERMINED TO BE EMBEDDED IN THE DERMAL LAYER OF THE SKIN. DOCTOR CONSULTED WITH OTHER PHYSICIANS WHO AGREED IT WAS NOT IN THE VASCULATURE. REMOVED THE FRAGMENT UNDER LATER THAT DAY. THE FRAGMENT WAS SENT TO PATHOLOGY AND IS 1.2CM IN LENGTH BY .01CM IN DIAMETER. NO INJURY TO PATIENT." ADDITIONAL INFORMATION REGARDING EVENT DETA

  Patient problems: No Code Available

  MAUDE report 7218177 ↗
• MalfunctionNov 30, 2017Fracture; Fracture

  IT WAS REPORTED THAT DURING INSERTION INTO A PREVIOUSLY IMPLANTED ILIAC STENT, THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET WIRE BROKE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072507 ↗