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VascuClear EVH (UDI 00803622132360)Recalls & reported problems

Livanova USA, Inc.

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00803622132360), received between Aug 24, 2016 and Dec 28, 2020 — classified as 4 malfunctions.

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

Most reported problems

Device problems

  • Break1
  • Detachment Of Device Component1
  • Detachment of Device or Device Component1
  • Disconnection1

Patient problems

  • No Consequences Or Impact To Patient4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 28, 2020Disconnection; Disconnection

    LIVANOVA USA INC HAS RECEIVED A REPORT STATING THE TIP OF THE EVH CATHETER BROKE DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY. LIVANOVA RECEIVED THE REPORT REF MW5097872.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11077170 ↗
  • MalfunctionMay 5, 2020Break; Break

    SEE INITIAL REPORT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10023456 ↗
  • MalfunctionOct 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

    LIVANOVA RECEIVED A REPORT THAT THE PLASTIC TIP OF THE VASCUCLEAR PRECISION BIPOLAR BROKE OFF DURING THE VEIN HARVESTING PROCEDURE AND WAS DEPOSITED IN THE PATIENT. THE TIP WAS REMOVED BY THE SURGEON AND THE DEVICE WAS SWAPPED OUT TO COMPLETE VEIN HARVESTING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8025103 ↗
  • MalfunctionAug 24, 2016Detachment Of Device Component; Detachment Of Device Component

    SORIN GROUP RECEIVED A REPORT THAT A PIECE OF A BLADE GUARD IN THE VASCUCLEAR PRECISION BIPOLAR KIT BROKE OFF INSIDE THE LEG OF THE PATIENT DURING A PROCEDURE. THE PIECE WAS RECOVERED WITHOUT PATIENT INJURY AND THE KIT WAS SWITCHED OUT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5901480 ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.