CARDINAL HEALTH 68-1132Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885380153181), received between Jan 19, 2021 and Aug 4, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Melted” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022No Audible Alarm; Suction Failure; No Audible Alarm

  CUSTOMER REPORTED THAT THE NEGATIVE PRESSURE WOUND THERAPY CATALYST DEVICE WAS NOT PROVIDING SUCTION AND DID NOT ALARM TO ALERT CUSTOMER. CUSTOMER REPORTED THAT THERE WAS NO INJURY AND NO FOLLOW UP CARE DUE TO THE DEVICE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15168264 ↗
• MalfunctionJul 11, 2022No Audible Alarm; Suction Problem; Suction Failure; No Audible Alarm; Suction Failure

  THE NURSE CALLED THE CARDINAL HEALTH AFTER HOURS SUPPORT DESK, TO REPORT THAT THE NEGATIVE PRESSURE WOUND THERAPY DEVICE WAS NOT PROVIDING SUCTION AND WHEN THE TUBING CLAMP WAS PRESSED DOWN IT WOULD NOT ALARM. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION, CLINICAL DATA, OR PATIENT DEMOGRAPHICS WAS PROVIDED WHEN REQUESTED. THE NURSE SENT THE DEVICE TO THE DISTRIBUTOR, WHO DID NOT FIND AN ISSUE WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14980682 ↗
• MalfunctionJun 24, 2022No Audible Alarm; Device Alarm System; No Audible Alarm; Suction Failure

  NURSE REPORTED THAT THE CATALYST DEVICE WAS NOT PROVIDING SUCTION. THE FOAM DRESSING WAS NOT DRAWN DOWN COMPLETELY, AND THE DEVICE WAS NOT ALARMING. NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE EVENT DATE IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14808806 ↗
• MalfunctionMar 2, 2022Device Alarm System; Decrease in Suction; Device Alarm System; Decrease in Suction

  CUSTOMER REPORTED THAT THE DEVICE ALARM WAS NOT BEEPING WHEN THERE WAS AN AIR LEAK AND IT WAS NOT HOLDING PRESSURE WELL. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657108 ↗
• MalfunctionSep 21, 2021Melted; Overheating of Device

  DISTRIBUTOR RETURNED THE NPWT CATALYST DEVICE SERIAL # (B)(4) DIRECTLY TO OUR SERVICE CENTER. UPON RECEIPT AT SERVICE CENTER, DEVICE BACK PLATE , INTERNAL TUBING, WIRING AND THE MUFFLER WERE FOUND MELTED DUE TO PUMP OVERHEATING. THE END USER HAD REPORTED TO THE DISTRIBUTOR THAT THERE WAS NO ADVERSE EVENT TO PATIENT OR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508518 ↗
• MalfunctionSep 17, 2021Melted; Overheating of Device

  DISTRIBUTOR RETURNED THE NPWT CATALYST DEVICE DIRECTLY TO CARDINAL SERVICE CENTER. UPON RECEIPT AT SERVICE CENTER, DEVICE BACK COVER WAS FOUND TO BE MELTED DUE TO OVERHEATING OF THE PUMP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487749 ↗
• MalfunctionSep 13, 2021Suction Failure; Suction Failure

  A NURSE CALLED SAYING THAT THE PRESSURE SETTING LIGHTS ARE NOT LIT UP ON THEIR CATALYST DEVICE. WHEN SHE TRIED TO CHANGE THE PRESSURE SETTINGS, NO LIGHTS WOULD COME ON TO INDICATE WHICH PRESSURE SETTING WAS IN USE. SHE ALSO SAID THAT THE ALARM LIGHTS MAY NOT BE WORKING, BECAUSE WHEN ANOTHER NURSE CAME TO CHECK ON THE PATIENT, THE DRESSING WAS PUFFED UP AND NO LOW PRESSURE/LEAK ALARM WAS GOING OFF. THE PATIENT WAS PLACED ON A WET-TO-DRY DRESSING WHILE THEY WAIT FOR ANOTHER DEVICE. THE CUSTOMER REPORTED THE ACTUAL COMPLAINT SAMPLE WAS AVAILABLE FOR INVESTIGATION, BUT DID NOT USE THE PREPAID (B)(6) RETURN LABEL THAT WAS SENT. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465281 ↗
• MalfunctionSep 10, 2021Melted; Material Deformation; Melted

  DISTRIBUTOR RETURNED THE NPWT CATALYST DEVICE DIRECTLY TO OUR SERVICE CENTER. UPON RECEIPT AT SERVICE CENTER, DEVICE BACK COVER WAS FOUND TO BE DEFORMED DUE TO OVERHEATING OF THE PUMP THOUGH THIS DEVICE WAS REPORTED TO OUR DISTRIBUTOR AS A FULL CANISTER ERROR. DISTRIBUTOR WAS UNABLE TO PROVIDE ANY CLINICAL DATA FROM IT¿S END USER BUT DID STATE THERE WAS NO KNOWN INJURY OR ADVERSE EFFECT REPORTED FROM THE END USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457143 ↗
• MalfunctionSep 7, 2021Melted; Device Emits Odor; Overheating of Device; Defective Device; Melted

  DISTRIBUTOR RETURNED THE NPWT CATALYST DEVICE DIRECTLY TO OUR SERVICE CENTER. UPON RECEIPT AT SERVICE CENTER, DEVICE BACK COVER WAS DEFORMED DUE TO OVERHEATING AND THERE WAS AN ODOR. DISTRIBUTOR WAS UNABLE TO PROVIDE ANY CLINICAL DATA FROM IT¿S END USER BUT DID STATE THERE WAS NO KNOWN INJURY OR ADVERSE EFFECT REPORTED FROM THE END USER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432761 ↗
• MalfunctionJul 15, 2021Thermal Decomposition of Device; Fire; Melted; Smoking; Device Fell

  CUSTOMER REPORTED THAT THE DEVICE CAUGHT ON FIRE AND THE FIRE DEPARTMENT WAS CALLED. THE RESIDENT GOT UP AT 4:30 IN THE MORNING TO USE THE RESTROOM AND THE NPWT DEVICE FELL OFF A TABLE, IT HIT THE FLOOR. THE RESIDENT PICKED UP THE DEVICE AND PLACED IT ON A CHAIR. THE DEVICE STARTING SMOKING AND MELTING AT THE SAME TIME. THE SMOKE FILLED THE ROOM AND SET OFF THE FIRE ALARMS WHICH CALLED THE FIRE DEPARTMENT TO ARRIVE ON THE SCENE. THE DEVICE WAS MOVED OUTDOORS. THE DEVICE WAS MELTED AROUND THE BATTERY COMPARTMENT AND THE CHAIR WAS ALSO MELTED. THE RESIDENT WAS MOVED OUT OF THE ROOM AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173087 ↗
• MalfunctionJul 13, 2021No Audible Prompt/Feedback; Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  CUSTOMER REPORTED DEVICE DID NOT HAVE AUDIBLE ALARM TO ALERT STAFF WHEN DRESSING WAS LOOSE OR WHEN THERE WAS A LEAK. THERE WAS NO INJURY OR ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12161886 ↗
• MalfunctionJan 19, 2021Melted; Overheating of Device

  CUSTOMER REPORTED THE BACK OF THE PLUGGED IN NPWT DEVICE THAT WAS SITTING ON THE PATIENT¿S DRESSER GOT TOO HOT TO THE TOUCH FOR THE NURSE AND WARPED AND MELTED THE PLASTIC BACKING OF DEVICE. NO INJURY OCCURRED. MDR BEING FILED FOR POTENTIAL HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197688 ↗