VSI IPN039061Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156103149), received between Aug 31, 2020 and Aug 8, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: PATIENT UNDERGOING LEFT HEART CATHETERIZATION. WHEN REMOVING 4FR MICRO SHEATH, MD NOTICED PART OF THE SHEATH WAS MISSING. MD DID NOT AGGRESSIVELY PULL ON SHEATH. HE CHECKED UNDER FLUORO AND DID NOT SEE THE MISSING PIECE. HE INSERTED A 6FR GUIDE, INTERVENTIONAL WIRE AND BALLOON IN AN ATTEMPT TO BLINDLY SNARE THE MISSING PIECE BUT WAS UNSUCCESSFUL. PRIOR TO PULLING SHEATH, ASPIRATED APPROX. 20 ML BLOOD AND SHEATH PULLED WITHOUT PRESSURE UNTIL REMOVED FROM PATIENT THEN IMMEDIATE MANUAL PRESSURE FOR 15 MINS TO ENSURE SUCCESSFUL HEMOSTASIS. SITE REMAINED SOFT, NOT HEMATOMA AND DRY OCCLUSIVE DRESSING APPLIED. 6FR SHEATH WAS FLUSHED TO SEE IF BROKEN PIECE OF 4FR SHEATH WAS PRESENT. NO EVIDENCE OF BROKEN 4 FR SHEATH. MD AND PATIENT UPDATED AFTER SHEATH PULL. PATIENT DENIED ANY COMPLAINTS, REMAINS HEMODYNAMICALLY STABLE. ADDITIONAL INFORMATION: APPROX 5CM OF THE DEVICE SEPARATED IN THE RIGHT FEMORAL ARTERY. THERE WAS NO ISSUES ON ACCESS. THE VESSEL HAD NO REPORTED TORTUOSITY OR CALCIFICATION. THE SEPARATED DEVICE WAS NOT SEEN ON FLOROSCOPY AND THERE IS NO ADDITIONAL INTERVENTIONS PLANNED. THE PATIENT IS REPORTED AS FINE WITH NO REPORTED HARM OR CONSEQUENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17478091 ↗
• InjuryAug 31, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE INSERTION A PART OF THE MICROPUNCTURE SHEATH SHEARED OFF, WHICH WAS DISCOVERED AFTER REMOVAL. SCANNING THE CHEST WITH FLUOROSCOPY WITH PHYSICIAN THERE IS AN ARTIFACT IN THE RIGHT MIDLUNG WHICH MAY HAVE REPRESENTED THIS, BUT IT APPEARS TO BE NOT FULLY IN THE PULMONARY ARTERY. AFTER DISCUSSION IT WAS FELT THAT ATTEMPTS AT REMOVING THIS WOULD RESULT IN MORE HARM THAN GOOD. NO ADVERSE HEMODYNAMIC EVENTS NOTED. NO FURTHER COMPLICATIONS WERE REPORTED. MEDWATCH (B)(4) RECEIVED FROM SITE 06AUG2020

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10474845 ↗