V•Stick™ Vascular Access Set 391505300ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886333004232), received between Jun 9, 2022 and Nov 5, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

• MalfunctionNov 5, 2022Break

  EARLY 40'S MALE WITH HISTORY OF VENTRICULAR TACHYCARDIA. PROCEDURE IMPLANTATION OF CARDIAC DEFIBRILLATOR DURING THE PROCEDURE THE DISTAL TIP OF THE ARGON VASCULAR MICRO PUNCTURE WIRE BROKE OFF AND CAUSED AN EMBOLISM IT WENT FROM THE LEFT SUBCLAVIAN VEIN TO THE DISTAL PULMONARY ARTERIAL SYSTEM RETRIEVAL WAS ATTEMPTED IN THE LEFT FEMORAL VEIN UNSUCCESSFUL PATIENT KEPT THE NIGHT AND DISCHARGED THE NEXT DAY ASYMPTOMATIC . PROJECTED OUTCOME GOOD. PATIENT ASYMPTOMATIC UPDATE PER EMAIL: ¿AN INCISION WAS MADE OVER THE PULSE GENERATOR. THE OLD GENERATOR WAS REMOVED FROM THE POCKET. THE LEADS WERE REMOVED FROM THE DEVICE AND TESTED. THE LEADS WERE REMOVED FROM THE POCKET AND HAD MODERATE FIBROSIS. THE RV/ICD LEAD HAD ADEQUATE PACING CAPTURE THRESHOLDS AND SENSING. ATRIAL SENSING AND CAPTURE THRESHOLDS WERE ADEQUATE. THE LEFT SUBCLAVIAN VEIN WAS ACCESSED ONCE OVER THE 1ST RIB WITH A MICROPUNCTURE NEEDLE AND MICROPUNCTURE WIRE AFTER A VENOGRAM WAS PERFORMED. ACCESS WAS DIFFICULT DUE TO THE EXISTING LEADS, FIBROSIS, AND CHANGES IN ANATOMY DUE TO LONGSTANDING INDWELLING LEADS. IN THE PROCESS OF TRYING TO ACHIEVE ACCESS, THE TIP OF THE MICROPUNCTURE WIRE FRACTURED AND EMBOLIZED, EVENTUALLY MAKING

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 15741090 ↗
• InjuryOct 25, 2022Break

  EARLY 40¿S MALE WITH HISTORY OF VENTRICULAR TACHYCARDIA. PROCEDURE: IMPLANTATION OF CARDIAC DEFIBRILLATOR. DURING THE PROCEDURE, THE DISTAL TIP OF THE ARGON VASCULAR MICRO PUNCTURE WIRE BROKE OFF AND CAUSED AN EMBOLISM. IT WENT FROM THE LEFT SUBCLAVIAN VEIN TO THE DISTAL PULMONARY ARTERIAL SYSTEM. RETRIEVAL WAS ATTEMPTED IN THE LEFT FEMORAL VEIN, UNSUCCESSFUL. PATIENT KEPT THE NIGHT AND DISCHARGED THE NEXT DAY, ASYMPTOMATIC. PROJECTED OUTCOME GOOD. PATIENT ASYMPTOMATIC. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, V¿STICK¿ VASCULAR ACCESS SET (PER SITE REPORTER).

  Patient problems: Foreign Body Embolism

  MAUDE report 15671505 ↗
• MalfunctionSep 19, 2022Unraveled Material; Patient Device Interaction Problem

  PATIENT HAD A VERY NARROW SUBCLAVIAN VEIN WITH CLOT OR STENOSIS. WIRE UNRAVELLED AS THE PHYSICIAN WAS PULLING THE WIRE BACK/WITHDRAWING THE WIRE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 15445947 ↗
• MalfunctionJun 9, 2022Unraveled Material

  THE WIRE UNRAVELED WILL INSERTED/ADVANCED IN TO THE VEIN, THE WIRE HAD TO REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643737 ↗