CARDINAL HEALTH 6708888Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885380103520), received between Sep 1, 2020 and Apr 13, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2022Device Alarm System; Suction Failure

  CUSTOMER REPORTED THE DEVICE WAS NOT SUCTIONING AND THERE WAS A FAILURE TO ALARM. THERE WAS NO PATIENT INJURY, AS THE DEVICE WAS IMMEDIATELY REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107033 ↗
• InjuryJan 7, 2022Leak/Splash; Suction Problem; Suction Problem

  CARDIAC SURGEON REPORT STATED THAT A PATIENT USING A NEGATIVE PRESSURE WOUND THERAPY DEVICE AND HAS REPORTED THE PATIENT TO BE IN SEPTIC SHOCK DUE TO UNIT REPORTEDLY LEAKING. PATIENT WAS ADMITTED TO ICU.

  Patient problems: Sepsis; Septic Shock

  MAUDE report 13193890 ↗
• InjuryDec 10, 2021Decrease in Suction; Suction Problem; Suction Problem

  CUSTOMER REPORTED NURSE MANAGER HAD A MALE PATIENT WITH STERNAL INCISION THAT DEHISCED, SO THE NEGATIVE PRESSURE WOUND THERAPY PRO DEVICE WAS PLACED ON THIS COMPLEX CHEST WOUND. WHEN HE CAME HOME, HE HAD A LOT OF DRAINAGE, AND WAS ON IV ANTIBIOTICS, THE ANTIBIOTICS CEASED BUT THEY WERE STILL DOING 5X VISITS A WEEK BECAUSE THEY FELT THE SUCTION WASN'T WORKING PROPERLY AND THE PATIENT KEPT EXPERIENCING ISSUES WITH POOLING UNDER THE DRESSING. THE DRESSING HAD A GOOD SEAL, BUT THE PUMP WAS JUST NOT REMOVING ALL THE EXUDATE. THEY CHANGED THE PUMP FOR A NEW PRO DEVICE ON NOV 10 WORRIED THAT IT WAS A PUMP ISSUE, AND HE DID FEEL THERE WAS IMPROVED SUCTION WITH IT. UNFORTUNATELY, BECAUSE OF THE POOLING OF FLUID, HE ALSO HAD A LOT OF MACERATION BY THEN. HE ALSO DEVELOPED A FLUID FILLED POCKET AT THE BOTTOM OF THE WOUND. OVER THE WEEKEND (NOV 13-14) THE CLIENT WAS ADMITTED TO HOSPITAL WITH AN INFECTED WOUND SITE.

  Patient problems: Fluid Discharge; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 12978298 ↗
• MalfunctionSep 1, 2020Device Displays Incorrect Message

  NO ALARM WENT OFF AND THE MACHINE CONTINUED TO ATTEMPT TO GET SUCTION/SEAL. TWO NEGATIVE PRESSURE WOUND THERAPY DEVICES WERE ATTEMPTED ON THE SAME PATIENT. THE LOT/SERIAL NUMBER FOR THIS ONE IS (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10480270 ↗
• MalfunctionSep 1, 2020Defective Alarm; Self-Activation or Keying

  NO ALARM WENT OFF AND THE MACHINE CONTINUED TO ATTEMPT TO GET SUCTION/SEAL. TWO NEGATIVE PRESSURE WOUND THERAPY DEVICES WERE ATTEMPTED ON THE SAME PATIENT. THE LOT/SERIAL NUMBER FOR THIS ONE IS (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10480135 ↗