VSI IPN916039Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10841156107079), received between Jan 13, 2022 and Apr 10, 2025 — classified as 3 injuries, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "MICRO INTRODUCER BROKE IN HALF AND THE DISTAL PORTION WAS STUCK INSIDE THE PATIENT'S VEIN. A SNARE WAS USED TO REMOVE IT." ADDITIONAL INFORMATION: "IT WAS SUBCLAVIAN VENOUS ACCESS FOR PPM LEAD PLACEMENT. THERE WAS NO CALCIFICATION."

  Patient problems: Foreign Body In Patient

  MAUDE report 21812217 ↗
• MalfunctionFeb 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "DR. WAS USING A MICRO PUNCTURE IN FEMORAL ACCESS CASE AND THE WIRE SNAPPED WHEN IN USE ON PATIENT". HE WAS PERFORMING A FISTULAGRAM. THE WIRE SEPARATED FROM THE FLOPPY END TO THE MANDREL. THEY WERE HAVING A HARD TIME ACCESSING INTO THE FISTULA, THEY THEN TRIED TO ACCESS FROM OPPOSITE END WITH WIRE-THEY BELIEVE THE WIRE GOT CAUGHT IN STENT STRUTS AND THEY SEPARATED. THEY TRIED SNARING THE FLOPPY END OF WIRE THAT WAS LEFT INSIDE PATIENT BUT WERE UNABLE TO RETRIEVE IT. THEY THEN USED A BIOPSY ACCESS KIT TO GET THE WIRE OUT. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH NO ISSUES, PATIENT WAS IN GOOD CONDITION. THERE WAS NO PATIENT HARM AND THEY WERE REPORTED AS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409325 ↗
• MalfunctionJan 9, 2023Break; Physical Resistance/Sticking

  DURING VENOUS ACCESS PORTION OF THE PROCEDURE, WIRE WAS DIFFICULT TO THREAD THROUGH NEEDLE AND UPON REMOVAL OF NEEDLE AND WIRE, ACCESS WIRE BECAME STUCK AND TIP OF WIRE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120918 ↗
• InjuryMay 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED VIA VOLUNTARY MEDWATCH 5108981. DURING USE ON A PATIENT: TELEFLEX STIFFEN MICRO-INTRODUCER WIRE BEING USED DURING A CARDIAC CATHETERIZATION BECAME LODGED IN THE DISTAL ABDOMINAL AORTA. DURING REMOVAL OF THE LODGED WIRE, A 12-15CM PIECE OF THE WIRE BROKE OFF THE INTRODUCER AND WAS UNABLE TO BE REMOVED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: TELEFLEX STIFFEN MICRO-INTRODUCER WIRE BEING USED DURING A CARDIAC CATHERIZATION BECAME LOGGED IN THE DISTAL ABDOMINAL AORTA. DURING REMOVAL OF THE LOGGED WIRE A 12-15CM PIECE OF THE WIRE BROKE OFF OF THE INTRODUCER AND WAS UNABLE TO BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14459389 ↗
• InjuryFeb 25, 2022Break; Break

  AS REPORTED: WIRE EMBEDDED IN TISSUE OR PLAQUE. ADDITIONAL INFORMATION FROM MEDWATCH (MW5106388) WAS RECEIVED ON 01FEB2022 - TIP OF INTRODUCER BROKE OFF DURING INSERTION AND BECAME EMBEDDED IN WALL OF LEFT FEMORAL ARTERY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13604342 ↗
• MalfunctionJan 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: DISTAL TIP OF WIRE BECAME ENTRAPPED IN THE LEFT COMMON FEMORAL VEIN. REACHED OUT TO THE CUSTOMER WITH NO FURTHER RESPONSE BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13251462 ↗