RADSTIC Radiology Microintroducer kit 0669045Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741074578), received between Nov 30, 2017 and Apr 15, 2022 — classified as 1 death, 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "COMPLICATED MIDLINE INSERTION IN A PATIENT WITH LOW VENOUS CAPITAL WITH A FIRST GUIDE INSERTION FAILURE. THE SECOND GUIDE USED IS INSERTED UP TO AN OBSTACLE, IT REMAINS STUCK. REMOVAL BY THE NURSE OF THE GUIDE + NEEDLE. A FRAYED/LOOSE GUIDE WAS FOUND. IN TOTAL: FRAGMENTATION OF THE GUIDE WITH A FOREIGN BODY LEFT IN THE INTRAVENOUS LINE. CONSEQUENCES FOR THE PATIENT: ENDOVASCULAR PROCEDURE UNDER LOCAL ANESTHESIA TO REMOVE THE FRAGMENT: FAILURE. THE FRAGMENT LEFT IN PLACE WITH INTRAPARIETAL PORTION AT THE LEVEL OF THE BASILIC VEIN. WEEKLY RADIOGRAPHIC MONITORING IS INSTITUTED FOR 1 MONTH WITH ANTICOAGULATION. THE INCIDENT WAS ISOLATED AND OCCURRED DURING ANESTHESIA."

  Patient problems: Foreign Body In Patient

  MAUDE report 14117958 ↗
• DeathApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOR AN INFANT (B)(6), WITH A HISTORY OF BRONCHIOLITIS HOSPITALIZED IN A SHEAVE WITH NON-INVASIVE VENTILATION SUPPORT AND THEN DISCHARGED TO GENERAL PEDIATRICS FOR FURTHER TREATMENT. READMITTED FOR ENDOCARDITIS WITH ANTIBIOTIC TREATMENT REQUIRED FOR 6 WEEKS. CATHETER INSTALLATION ON (B)(6) AT 5 P.M. TO BE ABLE TO CARRY OUT THE TREATMENT. TRANSFUSION NECESSARY FOR THE END OF A BRADYCARDIA THEN ABRUPT STOP AT 10.00 PM (5H AFTER INSTALLATION), IMMEDIATELY TAKEN CARE OF ON COMPRESSION HEMOPERICARDIUM, TAMPONADE AND TRANSFER TO INTENSIVE CARE UNIT, UNFAVORABLE DEVELOPMENT AND DEATH THE NEXT DAY AT 5 P.M.

  Patient problems: Cardiac Arrest; Death; Tachycardia

  MAUDE report 9984253 ↗
• MalfunctionNov 30, 2017Break

  FACILITY REPORTED TO THE SALES REP THAT THE WIRE SHEARED OFF WHILE INSERTING THE DEVICE. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7070624 ↗