Vascular Dilator Kit 200-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00803622112522), received between Oct 7, 2017 and Dec 5, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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 18, 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.

• MalfunctionDec 5, 2024Crack; Crack

  LIVANOVA USA INC. RECEIVED A REPORT THAT A 24FRENCH DRAIN PLUG DILATOR WAS CRACKED AT THE END DURING NORMAL USE ON A STIFF GUIDE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854531 ↗
• MalfunctionMar 8, 2022Sharp Edges; Sharp Edges

  LIVANOVA USA RECEIVED A REPORT THAT, AT THE UNPACKING OF THE VASCULAR DILATOR, THE TIP OF THE DILATOR WAS TOO SHARP. THE SURGEON ELECTED TO NOT USE THE DILATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693204 ↗
• InjuryMay 13, 2020Crack; Crack

  LIVANOVA USA IN HAS RECEIVED A REPORT THAT, DURING A FEMORAL CANNULATION FOR A PROCEDURE, THE TIP OF THE DILATOR CRACKED. ACCORDING TO CUSTOMER INFORMATION THIS CAUSE PATIENT VESSEL DAMAGE AT THE INSERTION POINT AND REQUIRING FEMORAL VENOUS REPAIR DURING THE SURGERY. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: Perforation of Vessels

  MAUDE report 10051039 ↗
• MalfunctionOct 7, 2017Unraveled Material; Unraveled Material

  LIVANOVA RECEIVED A REPORT THAT THE GUIDE WIRE OF THE ESTECH PERCUTANEOUS INSERTION DIALATOR KIT UNRAVELED AS IT WAS BEING REMOVED FROM THE PATIENT DURING A PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. HOWEVER, IT HAS BEEN REPORTED THAT THE PATIENT LATER EXPIRED DUE TO A MEDICAL CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6926968 ↗