VascuClear EVH (UDI 00803622132384)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00803622132384), received between Jul 18, 2017 and Jan 26, 2023 — classified as 2 injuries, 5 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2023Crack; Crack

  LIVANOVA USA RECEIVED A REPORT THAT PLASTIC PIECE OF THE ENDOSCOPIC VEIN HARVESTING SYSTEM BROKE OFF AND WENT IN SUCTION DURING A SURGERY. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245284 ↗
• MalfunctionOct 17, 2019Break; Break

  SEE INITIAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9201888 ↗
• MalfunctionJun 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  LIVANOVA HAS BEEN INFORMED THAT, AT THE END OF A PROCEDURE, WHILE TRYING TO REMOVE ENDOSCOPIC VEIN HARVESTING SYSTEM ENDOSCOPIC VEIN HARVESTING SYSTEM VC17 FROM THE PATIENTS LEG INCISION, THE TIP BROKE OFF IN THE PATIENT. THE PIECE WAS REMOVED AND NOTHING LEFT IN PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED. THERE IS NOT REPORT OF ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674497 ↗
• MalfunctionNov 20, 2018Overheating of Device; Overheating of Device

  LIVANOVA RECEIVED A REPORT THAT THE HANDLE OF THE VASCUCLEAR PRECISION BIPOLAR WAS NOTED TO BE WARM DURING A VEIN HARVESTING PROCEDURE AND THE PATIENT'S SKIN APPEARED REDDENED/BURNED. THE BIPOLAR WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE HOSPITAL BIOMEDICAL ENGINEER REPORTEDLY CHECKED THE CAUTERIZING MACHINE AND WAS UNABLE TO IDENTIFY ANY ISSUES. THOUGH THE FACILITY REPORTED THAT THE PATIENT EXPERIENCED REDDENED/BURNED SKIN, IT WAS ALSO REPORTED THAT THE PATIENT IS FINE. NO INTERVENTION TO PREVENT PERMANENT DAMAGE WAS REPORTED.

  Patient problems: Burn, Thermal

  MAUDE report 8092603 ↗
• MalfunctionJan 31, 2018Material Fragmentation; Material Fragmentation

  LIVANOVA RECEIVED A REPORT THAT THE TIP OF THE VASCUCLEAR PRECISION BIPOLAR BROKE INTO MULTIPLE PIECES DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7232127 ↗
• InjuryAug 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AUGUST 7, 2017, LIVANOVA USA RECEIVED A USER MEDWATCH REPORT (MW5071103) THAT THE LIGHT INSIDE THE "TROCAR" OF THE VASCUCLEAR PRECISION BIPOLAR BLISTERED THE LEFT LEG OF THE PATIENT IN 3 AREAS DURING A PROCEDURE. THE WOUND WAS DRESSED AND THE NURSE CHECKED ON THE PATIENT 48 HOURS AFTER THE PROCEDURE TO ENSURE NO HEMATOMA OCCURRED. THE CUSTOMER REPORTED THAT THE PATIENT IS PRESENTLY DOING WELL. ALL OTHER SIMILAR PRODUCTS WERE PULLED FROM STOCK FOR INVESTIGATION.

  Patient problems: Burn(s)

  MAUDE report 6833908 ↗
• InjuryJul 18, 2017Device Operates Differently Than Expected

  WHILE HARVESTING ENDOSCOPIC VEIN FROM THE LEFT LEG AND WHILE SURGEON WAS WORKING THE LIGHT INSIDE, THE TROCAR BLISTERED THE LEFT LEG IN 3 AREAS. ZEROFORM WAS APPLIED TO THE LEFT LEG AND WRAPPED WITH KERLIX AND ACE. WOUND NURSE WILL BE LOOKING AT WOUNDS THE DAY FOLLOWING THE PROCEDURE AND AFTER 48 HOURS OF WRAPPING TO PREVENT HEMATOMA PER PROTOCOL. FOLLOW-UP TO BE DOCUMENTED IN EMR. PRESENTLY THE PATIENT IS DOING WELL. SORIN VASCULAR ENDOSCOPIC VESSEL HARVESTING KIT WAS ALSO USED WITH ANOTHER SORIN PRODUCT CALLED PRECISION BIPOLAR, CAT. REFERENCE #PBDO2, LOT 1525100193 DUE TO EXPIRE IN SEPTEMBER 2018. ALL LIKE PRODUCTS WERE PULLED FROM STOCK. INVESTIGATION PER FDA OTHER MEDWATCH REPORTS WITH THIS DEVICE WERE FOUND IN FDA ARCHIVES FROM A FEW YEARS AGO - SEE LINK BELOW: HTTPS://ARCHIVE-IT.ORG/COLLECTIONS/7993?SHOW-ARCHIVEDPAGES&ALL=&EXACT=VEIN+HARVESTING&NONE=&HOST=&HITSPERDUPE-0&MIMETYPE-0&MONTH0-&YEAR0=&MONTH1=&YEAR1=&SEARCH=ADVANCED+SEARCH. COMPLICATIONS OF SURGERY/PROCEDURE: SURGERY/PROCEDURE NAME: CABG. COMPLICATION: ACCIDENTAL INJURY, I.E. PERFORATION/LACERATION HARM - TEMPORARY - INTERVENTION REQUIRED.

  Patient problems: Burn(s); Injury

  MAUDE report 6728341 ↗