VSI IPN029488Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10841156102913), received between Oct 8, 2019 and May 27, 2024 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT: "DURING ST-ELEVATION MYOCARDIAL INFARCTION, PATIENT WAS BROUGHT TO CATH LAB, MEDICAL DOCTOR ACCESSED LEFT GROIN, UPON GAINING ACCESS AND PUTTING IN THE 4F STIFFEN MICRO-INTRODUCER THE SHEATH BECAME DISLODGED INTO THE PATIENT'S BODY. WITH ASSISTANCE FROM VASCULAR SURGEON, THE DISLODGED SHEATH WAS RETRIEVED WITH SNARE."ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

  Patient problems: Insufficient Information

  MAUDE report 19400700 ↗
• MalfunctionApr 10, 2024Material Separation; Material Separation

  DR REPORTED THAT: " UPON REMOVAL OF INTRODUCER SHEATH THE DEVICE SEPARATED FROM THE HUB." AI RECEIVED ON 20MAR2024: "SHAFT OF SHEATH WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT. THERE WAS NO PATIENT HARM, INJURY OR HEALTH CONSEQUENCES REPORTED." ASSOCIATED COMPLAINTS: 2134812-2024-00014, 2134812-2024-00013 AND 2134812-2024-00015.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077347 ↗
• MalfunctionApr 10, 2024Material Separation; Material Separation

  DR REPORTED THAT: " UPON REMOVAL OF INTRODUCER SHEATH THE DEVICE SEPARATED FROM THE HUB." AI RECEIVED ON 20MAR2024: "SHAFT OF SHEATH WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT. THERE WAS NO PATIENT HARM, INJURY OR HEALTH CONSEQUENCES REPORTED." ASSOCIATED COMPLAINTS: 2134812-2024-00014, 2134812-2024-00013 AND 2134812-2024-00015.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077343 ↗
• MalfunctionApr 10, 2024Material Separation; Material Separation

  DR REPORTED THAT: " UPON REMOVAL OF INTRODUCER SHEATH THE DEVICE SEPARATED FROM THE HUB." AI RECEIVED ON (B)(6) 2024: "SHAFT OF SHEATH WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT. THERE WAS NO PATIENT HARM, INJURY OR HEALTH CONSEQUENCES REPORTED." ASSOCIATED COMPLAINTS: 2134812-2024-00014, 2134812-2024-00013 AND 2134812-2024-00015.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077329 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT: THE MIK WAS BROKEN AT THE HUB. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334356 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT: THE MIK WAS BROKEN AT THE HUB. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334264 ↗
• InjuryOct 7, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: UPON HAND INJECTION, SHEATH SEPARATED FROM HUB LEAVING SHEATH IN THE BODY. REMOVED WITH CUTDOWN TO REMOVE SHEATH. PATIENT IS REPORTED AS DOING WELL POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10641626 ↗
• InjuryDec 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING CARDIAC CATH PROCEDURE PHYSICIAN WAS GAINING ACCESS WITH MIK WHEN DEVICE BROKE IN THE ARTERY. PHYSICIAN HAD TO USE A SNARE TO REMOVE. PATIENT'S CURRENT CONDITION IS REPORTED AS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9418686 ↗
• MalfunctionOct 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  RECEIVED SUS VOLUNTARY REPORT MW5089562 ON 19SEP2019 PHYSICIAN ATTEMPTED ACCESS THROUGH A HIGHLY CALCIFIED VESSEL IN THE COMMON FEMORAL. DIFFICULTY EXPERIENCED DURING ACCESS. NITINOL WIRE WAS ADVANCED THROUGH THE NEEDLE, THEN RETRIEVED. UPON RETRIEVAL, A PORTION OF THE WIRE TIP WAS SHEARED OFF.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9167618 ↗