Micropuncture G07410Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002074101), received between Aug 3, 2016 and Jul 24, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2017Kinked; Stretched; Difficult to Advance

  IT WAS REPORTED THAT AFTER PUNCTURE, THE WIRE GUIDE WAS DIFFICULT TO ADVANCE INTO THE NEEDLE. THEREFORE, IT WAS REMOVED FROM THE PATIENT'S BODY. IT WAS CONFIRMED THAT THE WIRE GUIDE WAS STRETCHED AND KINKED. AS A RESULT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE ARE NO KNOWN ADVERSE EFFECTS TO THE PATIENT REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6737295 ↗
• MalfunctionJul 18, 2017Material Separation; Physical Resistance

  THE PHYSICIAN FELT RESISTANCE WHEN ATTEMPTING TO ADVANCE THE DEVICE OVER THE WIRE GUIDE. A VISUAL EXAMINATION OF THE DEVICE CONFIRMED THAT THE SHEATH SEPARATED FROM THE HUB. THE DEVICE WAS REPLACED WITH ANOTHER ONE.

  Patient problems: No Code Available

  MAUDE report 6721658 ↗
• MalfunctionJul 12, 2017Break

  IT WAS REPORTED THE USER FELT RESISTANCE DURING ADVANCEMENT OF THE DEVICE. SUBSEQUENTLY, THE DEVICE BROKE AT THE CONNECTOR. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6707637 ↗
• MalfunctionAug 3, 2016Unraveled Material; Failure to Advance; Unraveled Material; Failure to Advance

  IT WAS REPORTED THAT AFTER PUNCTURE, THE MICRO-PUNCTURE ACCESS SET WIRE GUIDE WAS INSERTED FROM THE SUBCLAVIAN VEIN. AS IT WOULD NOT ADVANCE, THE DEVICE WAS REMOVED AND FOUND TO BE KINKED AND UNRAVELED. ANOTHER DEVICE WITH THE SAME SPECIFICATIONS WAS USED TO COMPLETE THE TREATMENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5843005 ↗