VSI IPN916038Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10841156107086), received between Aug 17, 2021 and Oct 7, 2024 — classified as 3 injuries, 3 malfunctions.

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

• MalfunctionOct 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT " WHILE REMOVING MICROPUNCTURE TO DEPLOY ANGIOSEAL, TIP OF THE DILATOR BROKE OFF. RETRIEVED BY SNARE. CONTENTS BAGGED AND DELIVERED TO NSM.". ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER ON 25SEPT2024: "THE PATIENT DID NOT EXPERIENCE ANY NEGATIVE SYMPTOMS AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. THE PATIENT WAS DISCHARGED SAFELY THE SAME DAY. NO EMERGENCY TREATMENT WAS NECESSARY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382054 ↗
• MalfunctionSep 25, 2024

  WHILE REMOVING MICROPUNCTURE DILATOR TO DEPLOY ANGIOSEAL, TIP OF DILATOR BROKE OFF. RETRIEVED BY SNARE. CONTENTS BAGGED AND DELIVERED TO NSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300335 ↗
• InjuryAug 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE MICRO INTRODUCER HUB WAS SEPARATED FROM SHEATH. THE PATIENT WENT TO INTERVENTIONAL RADIOLOGIST (IR) SO THAT THE SHEATH COULD BE RETRIEVED. THE IR USED A SNARE TO REMOVE THE SHEATH FROM THE PATIENT. THE PATIENT WAS FINE AND HAD NO COMPLICATIONS. AS PER THE ADDITIONAL INFORMATION REPORTED, THE PROCEDURE PERFORMED WAS AN ABLATION PROCEDURE THROUGH A VENOUS FEMORAL ACCESS SITE. THE ACCESS WAS OBTAINED VIA ULTRASOUND AND THERE WERE NO ISSUES IN GAINING ACCESS TO THE VESSEL WITH THE MICRO INTRODUCER KIT. THE SHEATH WAS INSERTED WITH HIGHER-THAN-NORMAL SHEER PRESSURE DUE TO THE LARGE PATIENT PANNUS. THERE WAS NO HEAVY CALCIFICATION OR SCAR TISSUE AND THERE WAS NO VESSEL INJURY FROM SHEATH SEPARATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 17603608 ↗
• InjuryMay 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORT: HAD A MICRO-INTRODUCER KIT 7266V ,WHERE THE WIRE BROKE OFF IN THE PATIENT. UPON SITE VISIT TEAM STATED RADIAL ACCESS UNSUCCESSFUL USING SAME MICROINTRODUCER KIT. CONVERTED TO FEMORAL APPROACH. WIRE TIP SHEARED OFF WHILE REMOVING FROM INTRODUCER. SNARED A PORTION OF THE WIRE BUT REQUIRED A CUT-DOWN TO REMOVE REMAINING SEGMENT. WIRE TO BE SENT IN FOR INVESTIGATION. NO OTHER COMPONENTS SAVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14488355 ↗
• MalfunctionDec 6, 2021Break; Break

  AS REPORTED: CUSTOMER STATES THAT THE STIFFEN MICRO INTRODUCER TIP BROKE WHEN NEEDLE WAS PLACED IN IT. ADDITIONAL INFORMATION RECEIVED ON 22-NOV-2021: THE PROCEDURE WAS A LEFT HEART CATHERIZATION. THE CASE WAS COMPLETED WITH ANOTHER MICRO-INTRODUCER KIT (SAME MODEL). THE CURRENT PATIENT CONDITION IS REPORTED AS FINE. ADDITIONAL INFORMATION RECEIVED ON 01-DEC-2021: IT WAS CLARIFIED BY THE ACCOUNT, THAT THE SHEATH'S TIP IS WHAT BROKE ON THE MICRO-INTRODUCER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12938232 ↗
• InjuryAug 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: USED THE 4F MICROINTRODUCER KIT AND IT BROKE DURING USE; ABLE TO RETRIEVE ALL PIECES, AND NO FURTHER SURGICAL INTERVENTIONS NEEDED TO BE DONE. CASE WAS COMPLETED AS USUAL. SURGEON WAS ABLE TO REMOVE AFFECTED SHEATH OVER THE WIRE AND WITH THE HELP OF A HEMOSTAT RECOVER ALL PIECES. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12333731 ↗