Micropuncture G47950Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002479500), received between Aug 24, 2016 and Nov 17, 2025 — classified as 5 injuries, 8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 02DEC2025. PER THE REPORTER, THE PROCEDURE WAS PERFORMED IN A PATIENT ROOM BY AN INTERNIST. THE SEPARATED PORTION OF THE DEVICE WAS REMOVED IN THE INTERVENTIONAL RADIOLOGY (IR) DEPARTMENT. NO ADDITIONAL ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23573289 ↗
• InjuryFeb 14, 2023Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING INSERTION OF AN ARTERIAL LINE USING ULTRASOUND GUIDANCE, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET UNRAVELED AND SEPARATED. A PHYSICIAN'S ASSISTANT ACCESSED THE RIGHT RADIAL ARTERY AND BLOOD RETURN WAS OBSERVED. RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE WIRE GUIDE. THE NEEDLE AND WIRE WERE WITHDRAWN; HOWEVER, THE TIP OF THE GUIDEWIRE BECAME STUCK IN THE TISSUE AND UNRAVELED WITH GENTLE TRACTION. THE WIRE WAS REMOVED USING A SUTURE REMOVAL KIT AND FORCEPS, WITH APPLICATION OF GENTLE PROGRESSIVE TRACTION; HOWEVER, A PORTION OF THE WIRE REMAINED IN THE SUBCUTANEOUS TISSUE OF THE RIGHT WRIST. AN X-RAY NOTED A COILED WIRE JUST UNDER THE SKIN, NOT APPEARING TO INVOLVE THE RADIAL ARTERY. A VASCULAR SURGEON MADE A FIVE-MILLIMETER INCISION JUST PROXIMAL TO THE ORIGINAL PUNCTURE SITE. THE TISSUE WAS BLUNTLY DISSECTED AND THE RETAINED WIRE WAS VISUALIZED. FORCEPS WERE USED TO REMOVE THE WIRE. HEMOSTASIS WAS ACHIEVED AND STERI-STRIPS WERE APPLIED. A GAUZE DRESSING WAS TAPED IN PLACE. THERE HAS BEEN NO REPORT OF ANY ADDITIONAL PROBLEM WITH THE PATIENT'S WRIST. PER THE REPORTER, THE PATIENT IS VERY ILL AND REMAINED IN THE HOSPITAL AS OF (B)(6) 2023

  Patient problems: Foreign Body In Patient

  MAUDE report 16373622 ↗
• InjuryFeb 11, 2022Break; Unraveled Material; Break; Unraveled Material

  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 13513914 ↗
• InjuryNov 13, 2020Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10840068 ↗
• MalfunctionMar 11, 2020Unraveled 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 Known Impact Or Consequence To Patient

  MAUDE report 9820763 ↗
• MalfunctionMay 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING ACCESS FOR AN UNKNOWN PROCEDURE, THE DILATOR INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET SEPARATED AT THE HUB. THE DILATOR WAS INSERTED INTO THE FEMORAL ARTERY AND THE INNER PART OF THE DILATOR REPORTEDLY SEPARATED FROM THE HUB DURING USE. 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8599431 ↗
• MalfunctionFeb 28, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED IN SECTION H10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8379466 ↗
• InjuryJan 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A FISTULOGRAM, A WIRE INCLUDED IN A MICROPUNCTURE TRADITIONLESS ACCESS SET SEPARATED IN THE PATIENT. THE SEPARATION OCCURRED AS THE WIRE WAS BEING INSERTED THROUGH THE NEEDLE. IT WAS REPORTED THAT THE PATIENT MOVED DURING INSERTION OF THE GUIDE WIRE AT THE TIME OF THE SEPARATION. THE PATIENT'S ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED PER THE REPORTER. THE TIP WAS SUCCESSFULLY RETRIEVED THROUGH A SMALL INCISION, AND THE PATIENT'S OUTCOME HAS BEEN REPORTED AS "GOOD". 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 Code Available

  MAUDE report 8278590 ↗
• MalfunctionDec 13, 2017Stretched; Stretched

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE MICROPUNCTURE TRANSITIONLESS ACCESS SET DILATOR STRETCHED AS IT WAS WITHDRAWN FROM THE PATIENT'S GROIN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT ANATOMY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7114638 ↗
• MalfunctionJul 21, 2017Stretched; Stretched

  IT WAS REPORTED THAT AS THE PHYSICIAN WAS WITHDRAWING THE DILATOR FROM THE ARTERY, THE DILATOR STRETCHED. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT OUTCOME OR THE COMPLETION OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6731851 ↗
• MalfunctionJul 13, 2017Unraveled Material

  IT WAS REPORTED DURING A FEMORAL ACCESS PROCEDURE, THE WIRE GUIDE UNRAVELED AT THE TIP. THE PHYSICIAN WAS ABLE TO REMOVE IT WITH THE MICROPUNCTURE ACCESS CATHETER. THIS OCCURRED WITH 2 KITS, 2 DIFFERENT WIRES. 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 6710946 ↗
• MalfunctionDec 27, 2016Unraveled Material; Unraveled Material

  THE PHYSICIAN HAD AN ISSUE WITH A MICROPUNCTURE TRANSITIONLESS ACCESS SET WHERE THE WIRE GOT CAUGHT ON THE NEEDLE. THE WIRE WAS STRETCHED AND UNRAVELED BUT WAS ABLE TO BE FULLY REMOVED FROM THE PATIENT. THERE WAS SOME SUBCUTANEOUS AIR IN THE AREA THAT MADE USING THE ULTRASOUND DIFFICULT BUT THERE WAS NO PATIENT HARM OR ADDITIONAL PROCEDURES REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6206364 ↗
• MalfunctionAug 24, 2016Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED WHEN THE PHYSICIAN WAS ADVANCING THE MICROPUNCTURE TRANSITIONLESS ACCESS SET DILATOR OVER THE WIRE, THE DILATOR HUB SNAPPED AND THE TOP OF THE DILATOR WAS TWISTED. 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 5900468 ↗