VSI IPN029489Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841156102920), received between Oct 7, 2019 and May 1, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED "PATIENT UNDER GOING PERMACATH PLACEMENT ON EXTREMITY THAT HAD PREVIOUS CATHETER PLACEMENTS. THE PROVIDER NOTED THAT THE VEIN WAS OCCLUDED AND TRIED TO PUSH PASS THE OCCLUSION IN AN EFFORT TO ENSURE PATIENT DID NOT LOSE PLACEMENT IN EXTREMITY. HE WAS UNABLE TO PASS OCCLUSION AND WITHDREW GUIDE WIRE. ONCE WITHDRAWN IT WAS NOTED THAT TIP OF WIRE BROKE. CONTRAST VISUALIZATION WAS PERFORMED TO VERIFY OCCLUSION AND LOCATION OF TIP OF WIRE. IT WAS DETERMINED THAT VEIN WAS OCCLUDED WITHOUT FURTHER USE AND THAT TIP WAS IN A LOCATION THAT IT WOULD NOT MOVE OR CAUSE HARM." THE CURRENT CONDITION OF THE PATIENT IS "UNKNOWN" AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19220188 ↗
• InjuryAug 27, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE TIP OF THE WIRE BROKE OFF IN A PATIENT DURING A DIFFICULT ACCESS OF THE POPLITEAL VEIN. PROCEDURE ABORTED DUE TO THE INABILITY TO GAIN VEIN ACCESS WITH NEITHER THE VSI PRODUCT NOR THE COMPETITIVE PRODUCT. HEMOSTATS WERE USED TO TRY TO PULL OUT THE WIRE TIP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10460323 ↗
• MalfunctionOct 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  LOST PART OF THE DILATOR IN PATIENT DURING PROCEDURE. NOT NOTICED UNTIL SCRUB TECH NOTICED PART OF THE DILATOR WAS MISSING WHEN SHE NOTICED IT ON THE BACK TABLE. THEY FLUORO'D PATIENT BUT COULDN'T SEE THE DILATOR. EMBOLIZED AND STILL IN THE BODY. PATIENT WAS TREATED FOR SCHEDULED PROCEDURE THROUGH EXISTING ACCESS. LATER CT SCAN REVEALED IT IS STILL IN THE COMMON FEMORAL ARTERY AND DOCTOR IS DETERMINING WHETHER TO GO BACK IN AFTER IT OR LEAVE IT. AFTER MULTIPLE ATTEMPTS, NO FURTHER INFORMATION RECEIVED, HOWEVER, IMAGES WERE RECEIVED TO SUPPORT INVESTIGATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9167737 ↗
• InjuryOct 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  WIRE WAS SHEARED OFF BY MICRO PUNCTURE NEEDLE. MEDWATCH RECEIVED FROM SITE 12SEP19. UF/IMPORTER REPORT # (B)(4). ADDITIONAL INFORMATION RECEIVED 18SEP19: PER MD, MICROPUNCTURE WIRE THROUGH THE MICROPUNCTURE NEEDLE, BUT THE WIRE WOULD NOT ADVANCE MUCH BEYOND THE SITE OF THE NEEDLE PUNCTURE. MD DECIDED TO PULL WIRE BACK THROUGH THE MICROPUNCTURE NEEDLE OUT OF THE BODY ALONG WITH THE NEEDLE. HOWEVER, THE WIRE WOULD NOT COME OUT BACK INTO THE NEEDLE. MD DECIDED TO TAKE OUT THE WIRE AND NEEDLE TOGETHER AS ONE ASSEMBLY AND WHILE PULLING BOTH OF THEM OUT, FELT RESISTANCE, AND A BREAK IN THE WIRE. NEEDLE AND WIRE CAME OUT BUT COULD SEE TIP OF WIRE SHEARED AND FRACTURED AND TIP OF WIRE MISSING. FLUOROSCOPY FOUND PIECE OF TIP RETAINED IN SUBCLAVIAN VEIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9163448 ↗