V.A.C. VERAFLO™ ULTVFL05SMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849554001299), received between Apr 4, 2018 and Jan 9, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2018,, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: ON (B)(6) 2018, A DRESSING CHANGE WAS PERFORMED AND A FOREIGN MATERIAL ALLEGED TO BE V.A.C. VERAFLO¿ DRESSING WAS ADHERED TO PART OF THE WOUND THAT HAD BEEN SUTURED. THE PHYSICIAN ATTEMPTED TO REMOVE THE FOAM MANUALLY, BUT WAS UNSUCCESSFUL IN REMOVING ALL OF THE FOREIGN MATERIAL. ON (B)(6) 2018, A DEBRIDEMENT WAS PERFORMED TO REMOVE THE REMAINING FOREIGN MATERIAL. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS OF FEVER OR PAIN. ON (B)(6) 2018, KCI REPRESENTATIVE OBSERVED THE FOREIGN MATERIAL AND NOTED THE DRESSING WAS DISCOLORED DARK GREEN AND ALLEGEDLY EMITTED A FOUL ODOR. A CULTURE WAS OBTAINED (DATE UNKNOWN). ON 25-DEC-2018, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: THE WOUND TESTED POSITIVE FOR ESCHERICHIA COLI 2+ AND ENTEROCOCCUS <1+. THE WOUND INFECTION WAS CONSIDERED UNRELATED TO V.A.C.® THERAPY AS THE V.A.C.® WAS INITIALLY PLACED ON A WOUND WITH A SURGICAL SITE INFECTION. THE PATIENT CONTINUED V.A.C. VERAFLO¿ THERAPY ON (B)(6) 2018 AND SWITCHED TO V.A.C.® THERAPY ON (B)(6) 2018. NO ADDITIONAL INFORMATION AVAILABLE. ON 06-JAN-2019, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NUR

  Patient problems: Foreign Body In Patient

  MAUDE report 8231724 ↗
• InjuryApr 4, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: ON (B)(6) 2018, V.A.C.ULTA¿ THERAPY SYSTEM WAS APPLIED TO THE PATIENT'S INFLAMED STERNUM POST-OPERATIVE BLOOD VESSEL PROSTHESIS IMPLANTATION. THE PHYSICIAN REPORTEDLY OPTED TO NOT PLACE A NON-ADHESIVE DRESSING TO THE VASCULAR PROSTHESIS. ON (B)(6) 2018, THE CLINICIAN EXPERIENCED DIFFICULTY REMOVING THE V.A.C. VERAFLO¿ DRESSING DURING A DRESSING CHANGE, AND A SMALL AMOUNT OF BLOOD FROM THE VASCULAR PROSTHESIS WAS OBSERVED. ON (B)(6) 2018, BLEEDING WAS OBSERVED FROM THE PATIENT'S WOUND, AMOUNT IS UNKNOWN. THE PATIENT RECEIVED HEMOSTATIC TREATMENT BY COVERING THE VASCULAR PROSTHESIS WITH FIBRIN GAUZE, AND THE DOCTOR DISCONTINUED THE V.A.C.ULTA¿ THERAPY SYSTEM. ON (B)(6) 2018, THE PATIENT UNDERWENT RE-OPERATION WITH BLOOD VESSEL PROSTHESIS IMPLANTATION AS A PIN-HOLE IN THE VASCULAR PROSTHESIS WAS OBSERVED. ON MAR 09 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE REQUIRED MEDICAL INTERVENTION WAS A COMBINATION USE OF NON-ADHESIVE DRESSING TO VASCULAR PROSTHESIS. IT WAS ALSO REPORTED THAT IT IS UNCERTAIN IF THE KCI DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT'S CURRENT STATUS IS S

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7397435 ↗