CARDINAL HEALTH 6701132Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10885380097454), received between Feb 5, 2020 and Sep 25, 2023 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023No Audible Alarm; No Audible Alarm

  IT IS BEING REPORTED BY THE NURSE THAT THE PUMP DOES NOT ALARM WHEN THERE IS A LEAK, OR IF THE DRESSING IS COMPLETELY REMOVED. THE PATIENT WAS NOT AFFECTED BY THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808447 ↗
• MalfunctionJan 18, 2022Overheating of Device; Suction Problem; Device Alarm System; Overheating of Device; Suction Problem; Suction Failure

  CUSTOMER REPORTED THAT WHEN THE POWER WAS TURNED ON THE DEVICE, THERE WAS NO SUCTION EVEN AFTER TROUBLESHOOTING. THE DEVICE WAS NOT ALARMING TO ALERT THERE WAS NO SUCTION. NEW DEVICE WAS OBTAINED. THERE WAS NO INJURY OR ADVERSE EVENT REPORTED.

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

  MAUDE report 13282499 ↗
• MalfunctionDec 7, 2021Melted; Overheating of Device; Smoking

  CUSTOMER REPORTED THE DEVICE WAS "SMOKING" AND HOT TO THE TOUCH. DEVICE DISCONNECTED FROM BATTERY CHARGER AND REMOVED FROM PATIENT. BACK OF DEVICE SHOWS SIGNS OF MELTING - LIKELY WHERE THE BATTERY IS LOCATED.

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

  MAUDE report 12957493 ↗
• MalfunctionSep 28, 2021Device Alarm System; Suction Failure

  CUSTOMER REPORTED THAT THE DEVICE LOST IT¿S CAPABILITY TO SUCTION AND DID NOT ALARM TO ALERT THE NURSE. IT WAS ALSO NOTED THAT THERE WAS NO INJURY OR ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543954 ↗
• MalfunctionJul 9, 2021Output Problem

  CUSTOMER REPORTED THAT THE DEVICE WAS NOT ALARMING FOR LOW PRESSURE LEAK WHEN THERE WAS A LEAK. DEVICE WAS PROMPTLY DISCONTINUED AND A REPLACEMENT DEVICE WAS PLACED. NURSE FURTHER STATED THAT THERE WERE NO KNOWN INJURIES OR ADVERSE EFFECTS DUE TO THE REPORTED CONCERNS. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12140914 ↗
• MalfunctionJun 30, 2021No Audible Alarm; Suction Failure; Device Alarm System; No Audible Alarm; Suction Failure

  THE NURSE CALLED AFTER HOURS WITH CONCERNS ABOUT ONE OF THEIR DEVICES NOT ALARMING PROPERLY. SHE CAN CLAMP THE TUBING FOR OVER 30 MINUTES AND THE CANISTER FULL/BLOCKAGE ALARM WILL NOT GO OFF. SHE ALSO SAID THE LOW PRESSURE/LEAK ALARM DOES NOT GO OFF EVEN WHEN THE DRESSING IS NOT SUCTIONED DOWN.

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

  MAUDE report 12093106 ↗
• MalfunctionApr 26, 2021No Audible Alarm; Mechanical Problem; Suction Failure

  PATIENT REPORTED THAT THE DRESSING WAS NOT SUCTIONED DOWN INTO THE WOUND BED AND THE DEVICE ALARM DID NOT GO OFF TO ALERT. THE NURSE COULD NOT HEAR THE DEVICE MOTOR RUNNING WHEN TUBING WAS CLAMPED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729538 ↗
• MalfunctionApr 23, 2021Thermal Decomposition of Device; Melted; Overheating of Device; Melted; Overheating of Device

  THE DISTRIBUTOR REPORTED THE PCB BOARD AND WIRES ARE BURNED AND THE DEVICE NEEDS TO BE SERVICED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 11720363 ↗
• MalfunctionMar 26, 2021Melted

  THE BACK OF THE WOUND VAC WAS MELTING WHILE IN USE WITH A RESIDENT. THERE IS NO INJURY REPORTED AND THE DEVICE NEVER LOST ITS ABILITY TO SUCTION. THE RESIDENT HAS A LONG-STANDING INFECTION IN HER KNEE AFTER A PARTIAL REPLACEMENT WITH SUBSEQUENT VISITS FOR DRAINAGE OF THE KNEE. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

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

  MAUDE report 11574791 ↗
• MalfunctionMar 3, 2021Melted; Overheating of Device

  THE CUSTOMER REPORTED THE SVED NPWT DEVICE GOT SO HOT THAT IT MELTED WHILE PLUGGED INTO THE WALL AND THE CUSTOMER BELIEVES THE DEVICE WAS ON A RESIDENT, HOWEVER THEY CANNOT CONFIRM. NO FURTHER INFORMATION WAS PROVIDED UPON REQUEST.

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

  MAUDE report 11408050 ↗
• MalfunctionFeb 16, 2021Overheating of Device; Material Deformation

  CUSTOMER REPORTED THAT THE BACK OF THE NPWT SVED THERAPY DEVICE GOT HOT AND THEN QUIT WORKING. WHEN THE DISTRIBUTOR PICKED IT UP THE BACK OF THE UNIT WAS WARPED FROM THE HEAT. PER CUSTOMER, THERE WAS NO INJURY NOR DISRUPTION TO THE PATIENT'S THERAPY. THEY WERE ABLE TO REPLACE THE PUMP WITH A NEW ONE WITHIN 2 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335135 ↗
• MalfunctionFeb 16, 2021Melted; Overheating of Device

  CUSTOMER REPORTED THAT THE DEVICE HER PATIENT WAS USING GOT SO HOT IT STARTED MELTING THE FRONT OF THE DEVICE. THE DEVICE WAS STANDING STRAIGHT UP, BUT THE DEVICE GOT SO HOT THE FRONT STARTED MELTING AND HAS A BURN SPOT ON THE FRONT. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

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

  MAUDE report 11332838 ↗
• MalfunctionDec 31, 2020Defective Alarm; Suction Failure

  CARDINAL HEALTH CUSTOMER SERVICE LINE WAS CONTACTED BY NURSE (B)(6) ON TUESDAY (B)(6) 2020. SHE STATED THAT THE DEVICE WAS REPORTEDLY NOT PROVIDING SUCTION. REPORTED SHE HAD GONE THROUGH ALL THE TROUBLESHOOTING STEPS, HOWEVER, WAS NOT ABLE TO SOLVE THE ISSUE. THE DEVICE WAS REPORTEDLY NOT ALARMING, HOWEVER, THERE WAS ALLEGEDLY POOLING OF FLUID IN THE WOUND SITE. THE CUSTOMER PROCEEDED TO CONTACT HER DISTRIBUTOR FOR A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101198 ↗
• MalfunctionJul 21, 2020Defective Alarm; Suction Failure

  CUSTOMER REPORTED THAT THE ALARM ON THE NPWT DEVICE DID NOT ALERT THAT THERE WAS NO SUCTION. IT WAS FOUND THAT THE FOAM WAS NOT DEPRESSED INTO THE SACRAL WOUND AND FLUID WAS POOLING AROUND THE SEALED DRESSING. NO INJURY TO PATIENT WAS REPORTED AND A NEW DEVICE WAS APPLIED. MDR FILED FOR RISK TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304792 ↗
• MalfunctionJul 14, 2020Melted; Overheating of Device; Material Deformation; Overheating of Device

  CUSTOMER REPORTED THE DEVICE OVERHEATED MELTING THE LABELS AND DEFORMING THE CANNISTER WHILE IN USE ON PATIENT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10273600 ↗
• MalfunctionJul 7, 2020Melted; Overheating of Device

  DEVICE GOT HOT ENOUGH TO CAUSE SOME MELTING ON THE DEVICE. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST. CARDINAL HEALTH IS FILING A REPORT FOR POTENTIAL RISK.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10243078 ↗
• MalfunctionJun 29, 2020Defective Alarm; No Pressure

  REPORTEDLY THE NPWT SVED THERAPY DEVICE 6701132 SERIAL NUMBER (B)(4) WAS NOT ALARMING WHEN DRESSING COMES LOOSE, RESULTING IN NEGATIVE PRESSURE BEING LOST WITHOUT ALERTS. NO DECLINE TO THE WOUND WAS REPORTED ONLY DEVICE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10209249 ↗
• MalfunctionJun 29, 2020No Audible Alarm; Alarm Not Visible

  REPORTEDLY THE NPWT SVED THERAPY DEVICE 6701132 SERIAL NUMBER (B)(4) WAS NOT ALARMING WHEN DRESSING COMES LOOSE, RESULTING IN NEGATIVE PRESSURE BEING LOST WITHOUT ALERTS. ISSUE WAS FOUND DURING A ROUTINE DRESSING CHANGE. NO INJURY OR DECLINE TO WOUND REPORTED. NO PATIENT DEMOGRAPHICS OR FURTHER INFORMATION WAS PROVIDED UPON REQUEST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10208560 ↗
• InjuryJun 11, 2020Device Alarm System

  REPORTEDLY THE PRODUCT WAS NOT ALARMING WHEN THE DRESSING COMES LOOSE, RESULTING IN NEGATIVE PRESSURE BEING LOST WITHOUT ALERTS AND ALLEGEDLY LEADING TO WOUND INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10142748 ↗
• InjuryMay 15, 2020Device Alarm System

  CUSTOMER REPORTED THE DRESSING FROM NPWT SVED THERAPY DEVICE 6701132 WAS FOUND COMPLETELY REMOVED OFF THE PATIENT¿S SACRUM WHILE THE DEVICE REMAINED RUNNING A LITTLE OVER 5 MINUTES WITH NO ACTIVATION ALARM FOR A LOW-PRESSURE LEAK. THE NURSE STATED THE WOUND DID DETERIORATE A BIT AND THE PATIENT WILL BE GETTING IT DEBRIDED ON MONDAY. THE NURSE WAS NOT SURE IF THERE WAS ANY REAL SUCTION HAPPENING AND THAT IS WHY THE WOUND MAY HAVE DETERIORATED. PATIENT IS IN AN ACUTE CARE FACILITY RECEIVING AROUND THE CLOCK CARE AND WOUND CARE MANAGEMENT 3 DAYS A WEEK. HER WOUND BED CONTINUES TO PROGRESS WITH APPROPRIATE THERAPY IN PLACE.

  Patient problems: Tissue Damage

  MAUDE report 10061910 ↗
• InjuryMay 14, 2020Device Alarm System; Suction Problem

  CUSTOMER REPORTED THAT SINCE THE FOAM DRESSING WAS NOT SUCTIONED DOWN TO THE SACRAL WOUND AND THE DRESSING WAS VERY WET, THE NURSE HAD TO REMOVE THE DRESSING COMPLETELY AND PLACE IT ASIDE. THE SVEDRENT NEGATIVE PRESSURE WOUND THERAPY DEVICE CONTINUED TO RUN EVEN THOUGH THE DRESSING WAS OFF PATIENT AND IT TOOK QUITE A WHILE FOR THE DEVICE TO ALARM. A NEW DEVICE WAS THEN APPLIED. DEBRIDEMENT OF WOUND WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10058208 ↗
• MalfunctionApr 9, 2020Device Emits Odor; Overheating of Device

  CUSTOMER HAD REPORTED THAT THE TREATMENT NURSE HAD NOTED THE NEGATIVE PRESSURE WOUND THERAPY SVED THERAPY DEVICE 6701132 WAS BEEPING AND HAD A BURNING SMELL. NURSE ATTEMPTED TO PICK UP DEVICE FROM THE PATIENT¿S FOOT REST (IT WAS UPRIGHT, FREE TO AIR, NOTHING WAS AGAINST IT) BUT WHEN SHE GRABBED IT, THE SEVERE HEAT CAUSED HER REFLEXES TO DROP IT IMMEDIATELY, BEFORE CAUSING ANY THERMAL INJURY TO HERSELF. SHE THEN TURNED THE VAC OFF AND ASSESSED THE DEVICE AND NOTED THAT THE BACKSIDE OF THE UNIT, VERTICALLY, WAS A SOFTENED DARKENED AREA FROM THE HEAT. THERE WAS NO INJURY. CARDINAL HEALTH IS FILING AN MDR FOR MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9945871 ↗
• InjuryFeb 5, 2020Use of Device Problem

  IT WAS REPORTED TO CARDINAL HEALTH, THAT OUR CUSTOMER¿S PATIENT AT THE SHORT TERM REHAB FACILITY WHO HAD A NEGATIVE PRESSURE WOUND DEVICE APPLIED/6701132 WENT TO AN ER WITH A HIGH FEVER, HIGH BLOOD PRESSURE, AND AN ELEVATED WHITE BLOOD CELL COUNT. THE POWER TO THE DEVICE WAS TURNED OFF WHEN THE PATIENT ARRIVED AT THE ER. THE ER NURSE STATED THAT SHE WAS TOLD THE DEVICE WAS OFF BECAUSE THE DRESSING WAS DONE INCORRECTLY, BUT THE ER NURSE STATED THE DRESSING LOOKED INTACT BUT THAT THE CANISTER WOULD NOT LOCK INTO PLACE. CARDINAL HEALTH REP INDICATED THAT MAYBE THE DEVICE HAD BEEN DROPPED AND ONE OF THE CANISTER PEGS BROKE OFF INTO THE DEVICE. THE ER NURSE LOOKED AT THAT PART OF THE DEVICE AND DID SAY THAT A PEG WAS BROKEN OFF INTO THE MACHINE. THE ER NURSE REMOVED THE EXISTING WOUND DRESSING AND REPLACED IT WITH AN ALTERNATE DRESSING SINCE NO FURTHER SUPPLIES FROM THE PATIENT WERE AVAILABLE AND THERE WAS NO WAY OF KNOWING HOW LONG THE DEVICE HAD BEEN TURNED OFF. OUR CUSTOMER COULD NOT PINPOINT THE CAUSE OF THE PATIENT¿S SYMPTOMS AT THE TIME OF THE ER ADMISSION.

  Patient problems: Fever; High Blood Pressure/ Hypertension; Test Result

  MAUDE report 9673582 ↗