VascuTape Radiopaque Tape 1108-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663100385), received between Mar 14, 2024 and Mar 14, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K932184); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2024Human-Device Interface Problem; Human-Device Interface Problem

  TAPE WAS NOT REMOVED FROM PATIENT'S LEG FOR TWO WEEKS AFTER PROCEDURE. PATIENT UNDERWENT MRI WITH TAPE INADVERTANTLY ON HIS LEG, RESULTING IN PAIN AND REDNESS, AS WELL AS BURN OF THE TAPE MARKINGS AS AN IMPRINT ON THE PATIENT'S LEG AFTER TAPE WAS FINALLY REMOVED. PATIENT HAD ANGIO PROCEDURE IN IR SUITE ON (B)(6) 2024, FOLLOWED BY LYSIS CASE THE FOLLOWING DAY; ISSUE AROSE WHEN MRI CONDUCTED 2 WEEKS LATER ON (B)(6) 2024 WITH TAPE STILL ON. PATIENT FINALLY REMOVED TAPE FROM HIS LEG (B)(6) 2024, SEVERAL DAYS AFTER MRI, AND OBSERVED THE REDNESS AND MARKINGS. TAPE MEASUREMENT MARKINGS WERE BURNED INTO PATIENT'S LEG DURING MRI; EXCORIATED DOWN TOWARDS THE ANKLE, PEELING AND RED. PATIENT IS BEING TREATED WITH WOUND CARE AND ANTIBIOTICS AND WAS DISCHARTED BUT FOLLOWED UP WITH BY IR SUITE ON (B)(6) 2024.

  Patient problems: Pain; Radiation Burn; Skin Inflammation/ Irritation

  MAUDE report 18907870 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932184. One submission often covers many models, so check the product and lot details in each record.

• Z-1054-2013 · Mar 18, 2013 · Terminated
  LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
• Z-1055-2013 · Mar 18, 2013 · Terminated
  Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
• Z-0434-2011 · Oct 22, 2010 · Terminated
  LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 100 strips Catalog Number: 1102-00 Intended to be placed on the patient's skin to assist during imaging procedures by ser
• Z-0435-2011 · Oct 22, 2010 · Terminated
  LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 30cm Tape, 100 strips Catalog Number: 1100-00 Intended to be placed on the patient's skin to assist during imaging procedures by s
• Z-0436-2011 · Oct 22, 2010 · Terminated
  LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips Catalog Number: 1108-20 Intended to be placed on the patient's skin to assist during imaging procedures by ser
• Z-0433-2011 · Oct 22, 2010 · Terminated
  LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 20 strips Catalog Number: 1102-20 Intended to be placed on the patient's skin to assist during imaging procedures by serv