Micro-Access Tearaway Introducer Kit KIT-010-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841268105133), received between Feb 10, 2023 and Feb 10, 2023 — classified as 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2023Break; Break

  GALT MEDICAL CORPORATION RECEIVED MEDWATCH 3500A FORM REPORT FROM FDA BY EMAIL UNDER TITLE MDR REPORT: (B)(4). DESCRIPTION OF THE PROBLEM STATED (RN WAS PLACING A NEW POLY MIDLINE. AFTER ACCESSING THE VEIN AND THREADING THE GUIDEWIRE, RN ATTEMPTED TO INSERT A DROP IN GALT INTRODUCER. A SMALL NICK WAS MADE PRIOR TO ATTEMPTING TO PLACE DILATOR/INTRODUCER, HOWEVER, DESPITE SUFFICIENT NICK IN SKIN, THE INTRODUCER WOULD NOT ADVANCE PAST THE PEEL-ABLE SHEATH. ADDITIONAL SMALL NICK MADE, AND DILATOR/INTRODUCER ATTEMPTED AGAIN, BUT STILL UNABLE TO ADVANCE PAST PEEL-ABLE SHEATH. INTRODUCER REMOVED AGAIN AND INSPECTED FOR DEFECT. UPON INSPECTION, SHEATH NOTED TO HAVE DEFECT AND WAS CURLED AND/OR PEELED BACK AT THE TIP. AS A RESULT, THE PATIENT EXPERIENCED MILD PAIN/DISCOMFORT AND MILD/MODERATE AMOUNT OF BLOOD LOSS. A CELOX PATCH WAS PLACED, AND PRESSURE HELD AT SITE FOR APPROXIMATELY 5 MINUTES BEFORE DRESSING APPLIED).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 16358063 ↗