Transitionless Micro-Introducer KitRecalls & reported problems across all models

We found 3 models of Transitionless Micro-Introducer Kit by Galt Medical Corp. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2018 and Nov 9, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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

Transitionless Micro-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. Mar 27, 2025Open, Classified

   Due to a potential open seal in the sterile barrier packaging.

   Z-1735-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported Transitionless Micro-Introducer Kit problems

Transitionless Micro-Introducer Kit models

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

• Transitionless Micro-Introducer Kit KIT-038-04

  Percutaneous Sheath Introducer Kit
  1 recall1 report
• Transitionless Micro-Introducer Kit KIT-038-03

  Percutaneous Sheath Introducer Kit
  3 reports
• Transitionless Micro-Introducer Kit KIT-038-02

  Percutaneous Sheath Introducer Kit
  1 report

Recent Transitionless Micro-Introducer Kit adverse event reports

The 5 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023

  DURING AN ATTEMPT TO PLACE A MIDLINE CATHETER, THE GUIDEWIRE BECAME STUCK IN THE PATIENT'S ARM (NOTED TO BE LOCATED IN SUBCUTANEOUS TISSUE). THERE WAS DIFFICULTY IN BACKING THE WIRE OUT, THEREFORE, VASCULAR SURGERY WAS CONSULTED. AS ATTEMPTS WERE BEING MADE AT WIRE REMOVAL BY VASCULAR SURGERY, THE WIRE BROKE. A MEDICAL DECISION WAS MADE TO LEAVE THE BROKEN PIECE OF THE WIRE INSIDE THE PATIENT. THIS WAS REPORTED AS THE 3RD TIME IN WHICH THIS PROCEDURALIST HAS SEEN THE WIRE TIP ENCIRCLE ITSELF INTO FORMING A SMALL KNOT. IN THE PREVIOUS 2 CASES, THE WIRE WAS SIMPLY REMOVED. IN THIS CASE, THE WIRE BECAME STUCK AND REQUIRED CONSULTATION BY VASCULAR SURGERY AND A TRIP TO THE OPERATING ROOM FOR ATTEMPTED REMOVAL OF THE WIRE. NOTE: THIS GUIDEWIRE WAS USED WHILE ATTEMPTING TO PLACE A BARD POWERMIDLINE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 18122243 ↗
• MalfunctionJul 15, 2022Break; Break

  AS RECEIVED BY EMAIL ON (B)(6) 2022 UNDER MDR REPORT NUMBER (B)(4) FROM FDA, DIVISION OF SURVEILLANCE SUPPORT, MEDICAL DEVICE REPORTING TEAM "MICRO PUNCTURE KIT WAS USED FOR GETTING ACCESS DURING PROCEDURE. PIECE OF WIRE BROKE OFF IN PATIENT. IT WAS ABLE TO BE RETRIEVED BUT THERE WAS A PORTION OF THE PLASTIC SHEATH THAT WAS LEFT IN THE PATIENT. FDA SAFETY REPORT ID# (B)(4)"

  Patient problems: Foreign Body In Patient

  MAUDE report 15028537 ↗
• InjuryFeb 25, 2021Break

  AS RECEIVED FROM SALES REP. (MICRO PUNCTURE BROKE OFF IN A PATIENT. COME TO FIND OUT THE WIRE SHEARED OFF, AND A PIECE OF THE WIRE GOT STUCK IN THE PATIENT). THE PATIENT IS OKAY. THE PIECE OF WIRE THAT SHEARED OFF DID OCCLUDE THE CIRCUMFLEX ARTERY. DOCTOR (B)(6) SAID THE PATIENT SHOULD BE FINE.

  Patient problems: Foreign Body In Patient; Occlusion

  MAUDE report 11380634 ↗
• MalfunctionDec 17, 2018Break

  AS RECEIVED FROM HEALTH PROFESSIONAL: PATIENT WAS PREPPED/ DRAPED IN STERILE FASHION. PER CARDIOLOGIST'S NOTES: A PERCUTANEOUS NEEDLE STICK WAS ACHIEVED THROUGH THE LEFT SUBCLAVIAN VEIN. A GUIDEWIRE WAS THEN INSERTED INTO THE LEFT SUBCLAVIAN VEIN. RESISTANCE WAS MET AND WHILE RETRACTING THE WIRE, THE TIP BROKE OFF. CONTRAST ANGIOGRAPHY WAS PERFORMED DEMONSTRATING THAT THE WIRE WAS NOT INTRAVASCULAR. ACCESS WAS THEN AGAIN ACHIEVED VIA MICROPUNCTURE UNDER ANGIOGRAPHY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8171754 ↗
• MalfunctionNov 30, 2018Break; Physical Resistance/Sticking

  PATIENT WAS PREPPED/ DRAPED IN STERILE FASHION. PER CARDIOLOGIST'S NOTES: A PERCUTANEOUS NEEDLE STICK WAS ACHIEVED THROUGH THE LEFT SUBCLAVIAN VEIN. A GUIDEWIRE WAS THEN INSERTED INTO THE LEFT SUBCLAVIAN VEIN. RESISTANCE WAS MET AND WHILE RETRACTING THE WIRE, THE TIP BROKE OFF. CONTRAST ANGIOGRAPHY WAS PERFORMED DEMONSTRATING THAT THE WIRE WAS NOT INTRAVASCULAR. ACCESS WAS THEN AGAIN ACHIEVED VIA MICROPUNCTURE UNDER ANGIOGRAPHY. MANUFACTURER RESPONSE FOR PERCUTANEOUS SHEATH INTRODUCER KIT, TRANSITIONLESS MICRO-INTRODUCER KIT (PER SITE REPORTER). REPORTED BY THE CARDIAC CATH LAB MANAGER TO MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8119529 ↗

Other Galt Medical Corp. products

• Tearaway Introducer Set6 models · 1 reports · 2 recalls
• 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
• Micro-Access Tearaway Introducer Kit3 models · 1 reports · 1 recall
• Centeze Centesis Catheter2 models · 0 reports · 1 recall