Micropuncture G36333Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00827002363335), received between Dec 12, 2014 and Nov 25, 2025 — classified as 13 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  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 23643648 ↗
• MalfunctionNov 24, 2025Contamination; Contamination

  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 23631317 ↗
• MalfunctionOct 27, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  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 23391865 ↗
• MalfunctionAug 11, 2025Unraveled Material; Unraveled Material

  AS REPORTED, DURING A PROCEDURE INVOLVING INSERTION OF A HEMODIALYSIS CATHETER, A MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S WIRE ¿SHEARED¿. PER THE REPORTER, RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OF THE WIRE; HOWEVER, SOME RESISTANCE WAS NOTED UPON REMOVAL. REPORTEDLY, THE PHYSICIAN WAS GENTLE AND REMOVED THE WIRE AND NEEDLE TOGETHER WHEN RESISTANCE WAS ENCOUNTERED, LOSING ACCESS; HOWEVER, THE WIRE ELONGATED AND UNRAVELED. A SECOND MPIS SET WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. WIRE FRAGMENTATION WAS NOT REPORTED. 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 22772274 ↗
• InjuryApr 22, 2024Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION RECEIVED 20JUN2024 STATING THE ACCESS SITE WAS NORMAL AND NOT SCARRED. VENOUS BLOOD ASPIRATED FREELY BEFORE WIRE GUIDE ADVANCEMENT. RESISTANCE WAS FELT DURING INSERTION OF THE WIRE AND ALSO FELT WHILE ATTEMPTING TO REMOVE THE GUIDE WIRE WHILE PULLING THE GUIDE WIRE BACKWARDS. AN ATTEMPT TO PULL THE ENTIRE WIRE BACK WITH THE ACCESS NEEDLE WAS MADE; HOWEVER, JUST THE NEEDLE WAS REMOVED. "GENTLE TRACTION" WAS USED TO PULL THE WIRE OUT, AND THE "SOFT PART" UNRAVELED BUT WAS IN ONE PIECE. FLUOROSCOPY GUIDED DISSECTION EASILY IDENTIFIED THE TIP OF WIRE. THE WIRE WAS ENTERING THE VEIN ON THE LATERAL WALL. THERE WAS NO OTHER ABNORMALITY DETECTED. THE PATIENT'S RECOVERY WAS DESCRIBED AS "UNEVENTFUL' FOLLOWING THE SURGICAL WIRE RETRIEVAL. THE FOLLOWING DAY, THE PATIENT UNDERWENT A FEMORAL APPROACH RIGHT HEART CATHETER PROCEDURE AND WAS DISCHARGED THAT SAME DAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154761 ↗
• MalfunctionJan 24, 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 18574728 ↗
• MalfunctionNov 16, 2022Difficult to Remove; Unraveled Material; Difficult to Remove; 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 15809542 ↗
• InjuryJun 22, 2022Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING CLOT REMOVAL OF THE UPPER EXTREMITY WITH POSSIBLE ANGIOPLASTY, STENTING, AND PLACEMENT OF A TUNNELED DIALYSIS CATHETER, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET SEPARATED IN THE PATIENT UPON REMOVAL AND WAS UNABLE TO BE RETRIEVED. ACCESS WAS OBTAINED IN THE LEFT UPPER EXTREMITY. THERE WERE REPORTEDLY NO ADVERSE EFFECTS TO THE PATIENT, WHO DEVELOPED A MILD HEMATOMA DURING THE PROCEDURE. THE PATIENT WAS REFERRED TO AN INTERVENTIONAL RADIOLOGIST FOR POSSIBLE WIRE REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; Hematoma

  MAUDE report 14777052 ↗
• MalfunctionJun 13, 2022Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem

  AS REPORTED, THERE WAS FOREIGN MATTER/BODY NOTED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675006 ↗
• InjuryApr 20, 2022Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF A PORT, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET SEPARATED IN THE PATIENT UPON INSERTION. ACCESS WAS OBTAINED IN THE RIGHT INTERNAL JUGULAR VEIN. THE WIRE WOULD NOT ADVANCE AS THE USER ATTEMPTED TO PLACE IT THROUGH THE NEEDLE, AND IT WAS REPORTEDLY NOTED THAT THE WIRE WAS NOT IN THE VEIN. RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE WIRE, WHICH REPORTEDLY SEPARATED, LEAVING A FRAGMENT OF THE WIRE IN THE PATIENT. 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: Foreign Body In Patient

  MAUDE report 14163595 ↗
• MalfunctionFeb 10, 2022Unraveled Material; Unraveled Material

  AS REPORTED, DURING AN HEMODIALYSIS (HD) CATHETER PLACEMENT, A MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS BEING USED, AND IT UNCOILED WHILE INSIDE OF THE PATIENT. THE HD CATHETER WAS BEING PLACED, AND THE WIRE MET RESISTANCE. THE PHYSICIAN ATTEMPTED TO RETRACT THE WIRE, BUT IT UNCOILED IN THE PATIENT. THE WIRE WAS PULLED OUT AND NO WIRE WAS RETAINED. AN X-RAY WAS USED TO CONFIRM. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509624 ↗
• InjuryApr 19, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 04JUN2021. THE PROCEDURE WAS A CARDIAC CATHETERIZATION, WHICH WAS SUCCESSFULLY COMPLETED. THE WIRE WAS MANIPULATED AND/OR REMOVED FROM THE ENTRY NEEDLE. NO ADDITIONAL PROCEDURES WERE REQUIRED AND THE PATIENT WAS NOT HOSPITALIZED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11688427 ↗
• InjuryNov 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 24NOV2020. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY, USING THE COMPLIANT DEVICE. A MICROPUNCTURE WIRE AND ANOTHER MANUFACTURER¿S SHEATH WERE USED WITH THE DEVICE. NO COMPLICATIONS WERE NOTED WITH THE OTHER MANUFACTURER'S SHEATH.

  Patient problems: No Code Available

  MAUDE report 10854519 ↗
• MalfunctionMay 14, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED, A MICROPUNCTURE TRANSITIONLESS ACCESS SET BECAME OCCLUDED WHILE USING THE DEVICE FOR A RIGHT RADIAL ARTERIAL LINE. THE LINE HAD BEEN PLACED THE PREVIOUS DAY AND WAS USED FOR ARTERIAL BLOOD PRESSURE MONITORING AND ARTERIAL BLOOD GAS ANALYSIS IN A CRITICALLY ILL, MECHANICALLY VENTILATED PATIENT. AFTER BEING TRANSFERRED BETWEEN INTENSIVE CARE UNITS, BLOOD WAS UNABLE TO BE DRAWN FROM THE ARTERIAL LINE, WHICH HAD A POOR ARTERIAL WAVEFORM TRACING. THE ARTERIAL LINE DRESSING WAS REMOVED, AND IT WAS DISCOVERED THAT THE INTRODUCER, DESCRIBED AS THE STAINLESS STEEL WIRE GUIDE, WAS IN PLACE. THE ARTERIAL LINE WAS REMOVED. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10058282 ↗
• InjuryMay 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED, WHILE USING THE DEVICE AS AN ARTERIAL LINE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET BECAME OCCLUDED. THE DEVICE WAS USED FOR CONTINUOUS ARTERIAL BLOOD PRESSURE MONITORING IN A CRITICALLY ILL, MECHANICALLY VENTILATED, COVID-POSITIVE PATIENT IN THE INTENSIVE CARE UNIT WITH ACUTE HYPOXEMIC RESPIRATORY FAILURE AND ACUTE RESPIRATORY DISTRESS SYNDROME. BLOOD WAS UNABLE TO BE OBTAINED FROM THE RIGHT RADIAL ARTERIAL LINE AND THE ARTERIAL WAVEFORM WAS DAMPENED. THE PATIENT REPORTEDLY HAD A 4 FRENCH MICROPUNCTURE CATHETER WITH THE INTERNAL DILATOR STILL IN PLACE.

  Patient problems: No Information

  MAUDE report 10053497 ↗
• InjuryMay 11, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE VIA ACCESS IN THE FEMORAL ARTERY, USING A MICROPUNCTURE TRANSITIONLESS ACCESS SET, THE HUB OF THE SHEATH SEPARATED FROM THE DEVICE. RESISTANCE WAS NOT REPORTED DURING INSERTION OR REMOVAL OF THE DEVICE, WHICH WAS USED FOR INITIAL ACCESS, AND THE ANATOMY WAS REPORTEDLY NORMAL. NO ANCILLARY DEVICES WERE REPORTEDLY USED WITH THE SHEATH. ACCESS WAS GAINED IN THE OPPOSITE FEMORAL ARTERY AND THE SHEATH WAS SNARED, USING A WIRE GUIDE AND UNKNOWN 7 FRENCH "IM" CATHETER. A COMPUTED TOMOGRAPHY ANGIOGRAM WAS COMPLETED. WHILE TRYING TO REMOVE THE DEVICE FROM THE ARTERY, A DISSECTION OCCURRED, EXTENDING FROM THE EXTERNAL ILIAC ARTERY TO THE COMMON FEMORAL AND SUPERFICIAL FEMORAL ARTERIES. AN ENDARTERECTOMY WITH BOVINE PATCH ANGIOPLASTY WAS THEN PERFORMED OF THE EXTERNAL ILIAC AND COMMON FEMORAL ARTERIES.

  Patient problems: No Code Available

  MAUDE report 10042813 ↗
• MalfunctionJul 31, 2019Material Separation; Material Separation

  AS REPORTED, WHILE GAINING RIGHT GROIN ACCESS FOR AN UNKNOWN PROCEDURE INVOLVING A PATIENT OF UNKNOWN AGE AND GENDER, A MICROPUNCTURE TRANSITIONLESS ACCESS SET WIRE, USED TO FACILITATE PLACEMENT OF A LARGER WIRE, SEPARATED INTO TWO PIECES. THE ACCESS SITE WAS NOT REPORTED TO BE SCARRED OR CALCIFIED AND RESISTANCE WAS NOT ENCOUNTERED. REPORTEDLY, THE WIRE "SHEARED OFF" INTO TWO PIECES AS THE DILATOR WAS PLACED OVER THE WIRE, LEAVING A SECTION OF THE DEVICE INSIDE THE PATIENT. THE SEPARATED PORTION WAS REMOVED AS THE PHYSICIAN "PULLED EVERYTHING OUT". THE DEVICE WAS NOT MANIPULATED OR REMOVED THROUGH A NEEDLE. 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 8845130 ↗
• InjuryJul 18, 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; No Code Available

  MAUDE report 8803000 ↗
• MalfunctionJul 16, 2019Device Damaged Prior to Use; 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 Patient Involvement

  MAUDE report 8796697 ↗
• InjuryJun 4, 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 Code Available

  MAUDE report 8666772 ↗
• InjuryDec 17, 2018Material 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 8171148 ↗
• InjuryJun 19, 2018Material Separation; Material Separation

  IT WAS REPORTED A WIRE FROM A "MICROPUNCTURE KIT" CAME APART AND, WHILE RETRIEVAL WAS ATTEMPTED, REMAINED LODGED IN THE PATIENT'S ANATOMY. 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; No Code Available

  MAUDE report 7615927 ↗
• InjuryMay 17, 2018Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. REFER TO FOR INVESTIGATION FINDINGS.

  Patient problems: Foreign Body In Patient

  MAUDE report 7523192 ↗
• MalfunctionJul 28, 2017Material Frayed

  IT WAS NOTED THAT THE WIREGUIDE WAS NOT VISIBLE DURING AN ULTRASOUND. UPON REMOVING THE WIRE THE END USER NOTED THE WIRE WAS FRAYED. NO PARTS OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THERE WERE NO ADDITIONAL PROCEDURES OR ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THIS COMPLAINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6750400 ↗
• MalfunctionJul 24, 2017Unsealed Device Packaging

  THE INFORMATION RECEIVED INDICATED THAT THE PACKAGE WAS NOT SEALED. THE OBSERVATION WAS MADE PRIOR TO USE, THERE WAS NO IMPACT TO THE PATIENT OR THE END USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6737665 ↗