3M™ Cavilon™ 3344Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30707387782376), received between Dec 4, 2019 and Dec 16, 2019 — classified as 1 injury, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2019Fire; Fire

  A REPRESENTATIVE REPORTED 3M¿ CAVILON¿ NO STING BARRIER FILM WAS ALLEGED TO HAVE CAUGHT ON FIRE WHILE ON A PATIENT. A VAC ULTRA THERAPY DEVICE AND A VERAFLO¿ CHOICE DRESSING WAS REPORTEDLY USED. THE REPRESENTATIVE REPORTED A (B)(6)-YEAR-OLD WHITE FEMALE DEVELOPED A QUARTER SIZE REDDENED AREA (BURN) TO THE RIGHT OF HER STERNUM. THE SKIN WAS PREPPED WITH POVIDONE IODINE. THE PATIENT WAS REPORTED TO HAVE AN ALLERGY HISTORY TO BACTRIM. NO OTHER SKIN SENSITIVITIES WERE SPECIFIED. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION. THERE WAS NO NOTATION OF ANY SKIN BREAKDOWN OR IRREGULARITY WHEN THE PATIENT WAS DISCHARGED FROM THE FACILITY.

  Patient problems: Erythema

  MAUDE report 9473677 ↗
• MalfunctionDec 4, 2019Fire; Fire

  (B)(6) REPORTED TO 3M THAT DURING THE INSTALLATION OF A VAC IN THE OPERATING ROOM, A VAC VERAFLO¿ KIT AND A VERAFLO¿ CHOICE DRESSING WAS USED. THE OPERATOR REPORTEDLY PUT DOWN THE 3M¿ CAVILON¿ NO STING BARRIER FILM (3344E) AND THE WIPE IGNITED FOLLOWING USE OF AN ELECTROSURGICAL KNIFE NEARBY. NO INJURIES WERE REPORTED. NO MEDICAL TREATMENT TO PATIENT WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9413474 ↗