Micro-Access Tearaway Introducer KitRecalls & reported problems across all models

We found 3 models of Micro-Access Tearaway Introducer Kit by Galt Medical Corp. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Feb 10, 2023 and Feb 10, 2023 — classified as 1 malfunction.

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

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Micro-Access Tearaway Introducer Kit recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 8, 2023Open, Classified

   Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.

   Z-1968-2023 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗

Most reported Micro-Access Tearaway Introducer Kit problems

Micro-Access Tearaway Introducer Kit models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Micro-Access Tearaway Introducer Kit KIT-010-12

  Percutaneous Sheath Introducer Kit
  1 recall0 reports
• Micro-Access Tearaway Introducer Kit KIT-010-17

  Percutaneous Sheath Introducer Kit
  1 recall0 reports
• Micro-Access Tearaway Introducer Kit KIT-010-04

  Percutaneous Sheath Introducer Kit
  1 report

Recent Micro-Access Tearaway Introducer Kit adverse event reports

The 1 most recent reports across all models, 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 ↗

Other Galt Medical Corp. products

• Tearaway Introducer Set6 models · 1 reports · 2 recalls
• Transitionless Micro-Introducer Kit3 models · 5 reports · 1 recall
• Micro-Introducer Kit5 models · 4 reports · 1 recall
• Transitionless Stiffen Micro-Introducer Kit3 models · 3 reports · 1 recall
• Stiffen Micro-Introducer Kit3 models · 2 reports · 1 recall
• Centeze Centesis Catheter2 models · 0 reports · 1 recall