Bard® Intra-abdominal Pressure Monitoring Device IAP001Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00801741121098), received between Jul 12, 2017 and Nov 30, 2022 — classified as 5 deaths, 103 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (47 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 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ALL OF THE 150 ML OF SALINE REMAINING IN THE BOTTLE WAS GONE AFTER 2 HOURS. THERE WERE NO SIGNS OF LEAKAGE ON THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15888015 ↗
• MalfunctionOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID LEAK OCCURRED FROM A PART OF THE INTRA-ABDOMINAL PRESSURE MONITORING DEVICE KIT ON THE DAY OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627010 ↗
• MalfunctionOct 13, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE INTRA ABDOMINAL PRESSURE MEASUREMENT KIT CAME IN PACKAGED A BIT DIFFERENTLY AND IT HAD CAUSED SOME CONFUSION. STATED THAT THE SYRINGE CAME UNATTACHED WHICH CAUSED A CONFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15596054 ↗
• MalfunctionAug 17, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT FROM THE THIRD DAY OF USE, WATER LEAKED FROM THE VICINITY OF THE CONNECTION BETWEEN THE TUBE AND THE INTRA ABDOMINAL PRESSURE (IAP) SAMPLE PORT ADAPTER. THE USER DID NOT PULL ON THE TUBE IN PARTICULAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15243381 ↗
• MalfunctionJun 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN INSTILLING SALINE INTO THE BLADDER TO MEASURE THE PRESSURE, SALINE LEAKED FROM THE TUBING THAT WAS FUSED TO THE CONNECTOR WHICH ATTACHED TO THE URINARY CATHETER DRAINAGE SYSTEM. THE SYSTEM WAS CHANGED OUT, AND THE NEW SYSTEM WAS ALSO LEAKING FROM THE SAME PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14670914 ↗
• MalfunctionJun 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN INSTILLING SALINE INTO THE BLADDER TO MEASURE THE PRESSURE, SALINE LEAKED FROM THE TUBING THAT WAS FUSED TO THE CONNECTOR WHICH ATTACHED TO THE URINARY CATHETER DRAINAGE SYSTEM. THE SYSTEM WAS CHANGED OUT, AND THE NEW SYSTEM WAS ALSO LEAKING FROM THE SAME PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14670886 ↗
• MalfunctionMar 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PRETEST, THE SYRINGE WAS UNABLE TO PULL. IT WAS STATED THAT THE DETAILS WERE UNKNOWN. ANOTHER DEVICE WAS USED WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840893 ↗
• MalfunctionOct 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE USER TRIED TO CONNECT THE INTRA ABDOMINAL PRESSURE MONITORING DEVICE AND USE AS USUAL, BUT LEAKAGE OCCURRED AT THE PART MARKED ON THE WHITE TAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12688718 ↗
• MalfunctionOct 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR INTRA ABDOMINAL PRESSURE MEASUREMENT KIT DEVICES WHICH ALL LEAKED AT THE VALVE TO THE POINT THAT FLUID WOULD NOT FLOW PROPERLY. FOUR DEVICES WERE ATTEMPTED TO BE USED ON THE SAME PATIENT. THEY WERE ABLE TO GET ONE TO WORK ENOUGH TO USE IT BUT IT ALSO LEAKED. PER CUSTOMER VIA PHONE ON (B)(6) 2021,THERE WERE 4 INTRA ABDOMINAL PRESSURE MEASUREMENT KITS WERE USED ON THE SAME PATIENT AND EACH ONE WAS NOTED TO BE LEAKING AFTER AN HOUR OR SO. A NEW KIT WAS THEN OPENED AND USED AND THERE WAS NO PATIENT HARM. PER FOLLOW UP VIA PHONE ON (B)(6) 2021, CUSTOMER STATED THE FLUID MENTIONED WOULD NOT FLOW PROPERLY WAS URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631926 ↗
• MalfunctionOct 5, 2021Fitting Problem; Difficult to Open or Close; Fitting Problem; Difficult to Open or Close

  IT WAS REPORTED THAT THE EZ-LOK VALVE PORT ON THE INTRA-ABDOMINAL PRESSURE SIDE DID NOT ROTATE AROUND AND COULD NOT CONNECT WELL WITH THE SAMPLE PORT OF URINE METER BAG 350 (PRODUCT NUMBER: 1532300J) AND EXPERIENCED URINE LEAKAGE. THE PATIENT OPENED A NEW BAG AND CONNECTED IT, BUT IT STILL COULD NOT CONNECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576728 ↗
• MalfunctionAug 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WATER LEAKED FROM THE AREA COVERED WITH RED TAPE NEAR THE SAMPLE PORT CONNECTOR OF THE INTRA-ABDOMINAL PRESSURE DEVICE. IT WAS USED USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352145 ↗
• MalfunctionJul 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON THE SECOND DAY OF USE, SALINE WAS FOUND TO LEAK BEYOND THE PUSHER INTO THE SYRINGE ATTACHED TO THE INTRA-ABDOMINAL PRESSURE MONITORING DEVICE. HOWEVER, THE SALINE SOLUTION DID NOT LEAK OUT OF THE SYRINGE. NO PRESSURE BAG WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233606 ↗
• MalfunctionJul 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE PLACEMENT OF THE INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, THE WATER LEAKED FROM NEAR THE EZ-LOCK. THERE WAS NO VISUAL DAMAGE LIKE A HOLE IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12227753 ↗
• MalfunctionJul 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN ATTEMPTED TO PLACE A URINARY CATHETER WITH INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, THE CONNECTION WHERE THE 2 DEVICES CONNECT, KEPT COMING APART. THE USER PUT A MICROCLAVE ON THE END OF THE CONNECTION, SINCE THE PATIENT DID NEED THE MONITORING. REPORTED LOT NUMBERS WERE NGER3336, NGER3337, NGER0722. PER FOLLOW UP VIA EMAIL ON (B)(6) 2021, THE ONLY PROBLEM REPORTED WAS THE CONNECTION BETWEEN THE URINE METER TUBING AND THE INTRA-ABDOMINAL TUBING. AS PER SAMPLE EVALUATION, NEW FAILURE WAS IDENTIFIED, IAP WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225273 ↗
• MalfunctionJun 28, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE LUER LOCK CONNECTION TO THE SAMPLING PORT WAS LOOSE AND BECOMES DISCONNECTED EASILY, BREAKING STERILITY. CUSTOMER STATED THAT IF NOT CLEANED ADEQUATELY PRIOR TO RE-CONNECTION, INTRODUCING BACTERIA INTO THE FOLEY, AND INCREASING CATHETER ASSOCIATED URINARY TRACT INFECTION RISK (CAUTION). ADDITIONALLY, THIS DID NOT COME WITH A TRANSDUCER AND TO SET THIS UP, CUSTOMER WAS CURRENTLY DISASSEMBLING AN ARTERIAL LINE TO REMOVE THE TRANSDUCER AND ATTACHING IT TO THE IAP SET UP. THIS ALSO INCREASES THE RISK FOR INFECTION, AS STERILE CONNECTIONS ARE BEING BROKEN TO OBTAIN ONE PIECE OF THE EQUIPMENT. WE HAVE ALSO NOTICED, IF THE YELLOW CAP AT THE END OF THE LUER-LOCK WAS DISCONNECTED PRIOR TO PRIMING, THE WHOLE LINE WOULD NOT PRIME WITHOUT KINKING THE END OF THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12074985 ↗
• MalfunctionJun 24, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE LUER LOCK CONNECTION TO THE SAMPLING PORT WAS LOOSE AND BECOMES DISCONNECTED EASILY, BREAKING STERILITY. CUSTOMER STATED THAT IF NOT CLEANED ADEQUATELY PRIOR TO RE-CONNECTION, INTRODUCING BACTERIA INTO THE FOLEY AND INCREASING THE CATHETER ASSOCIATED URINARY TRACT INFECTION (CAUTI). ADDITIONALLY, THIS DID NOT COME WITH A TRANSDUCER AND IN ORDER TO SET THIS UP, CUSTOMER WAS CURRENTLY DISASSEMBLING AN ARTERIAL LINE TO REMOVE THE TRANSDUCER AND ATTACHING IT TO THE INTRA-ABDOMINAL PRESSURE SET UP. THIS ALSO INCREASES THE RISK FOR INFECTION, AS STERILE CONNECTIONS ARE BEING BROKEN TO OBTAIN ONE PIECE OF THE EQUIPMENT. THEY HAVE ALSO NOTICED, IF THE YELLOW CAP AT THE END OF THE LUER-LOCK WAS DISCONNECTED PRIOR TO PRIMING, THE WHOLE LINE WOULD NOT PRIME WITHOUT KINKING THE END OF THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058351 ↗
• MalfunctionJun 20, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE INTRA-ABDOMINAL PRESSURE MONITORING DEVICE'S LUER CONNECTION POPPED OFF ALL THE TIME. NOT ONLY WHEN PATIENT MOVES OR THEY TAKING A PRESSURE READING. ALSO STATED THAT THE CONNECTION FELT LOOSE LIKE THE SAMPLING PORT WAS PUSHING IT OFF. USER WOULD LIKE THE EDUCATION ON PROPER SETUP AND CONCERNED ABOUT INCREASED RISK OF CATHETER ASSOCIATED URINARY TRACT INFECTION DUE TO THE LURE COMING OFF AND SET UPPED WITH A TRANSDUCER THAT WAS NOT PREPACKAGED IN THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Urinary Tract Infection

  MAUDE report 12030395 ↗
• MalfunctionJun 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WATER LEAK OCCURRED FROM THE SAMPLE PORT OF INTRA-ABDOMINAL PRESSURE MONITORING DEVICE AND USER DID NOT WANT TO USE IT FURTHER BECAUSE THE LOT NUMBER OF THE DEVICE WAS SIMILAR TO THE LOT NUMBER OF THE RECALLED INTRA-ABDOMINAL PRESSURE MONITORING DEVICE LOTS IN MARKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12030023 ↗
• MalfunctionJun 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK OCCURRED AT THE CONNECTING PART TO THE SAMPLE PORT WHEN CONNECTING THE IAP MEASUREMENT KIT. IT WAS STATED THAT THERE WAS A POSSIBILITY THAT THE PRODUCT WAS DEFECTIVE, OR THE OPERATION WAS NOT PERFORMED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957984 ↗
• MalfunctionMay 30, 2021Disconnection; Component Misassembled; Disconnection; Component Misassembled

  IT WAS REPORTED THAT THE WATER DID NOT FLOW APPROPRIATELY FROM THE INTRA ABDOMINAL PRESSURE MONITORING DEVICE KIT DUE TO CONNECTION FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905862 ↗
• MalfunctionApr 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FLUID STARTED LEAKING OUT BY THE PATIENT AT THE CONNECTOR PIECE IN THE BARD MEASUREMENT KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711938 ↗
• MalfunctionMar 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LIQUID LEAK FROM THE CONNECTOR OF THE SAMPLE PORT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM IBC ON 15MAR2021, IT WAS UNKNOWN THAT LIQUID LEAKED FROM THE SAMPLE PORT WAS WHETHER WATER OR URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572562 ↗
• MalfunctionMar 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE WATER LEAKED FROM THE BASE OF THE CONNECTION TO THE SAMPLE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553277 ↗
• MalfunctionFeb 4, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN ATTEMPTED TO PLACE THE URINARY CATHETER WITH AN INTRA ABDOMINAL PRESSURE MONITORING DEVICE, THE CONNECTION WHERE THE 2 DEVICES CONNECT, KEPT COMING APART. THE USER PUTS A MICRO CLAVE ON THE END OF THE CONNECTION, SINCE THE PATIENT NEEDED THE MONITORING. PER FOLLOW UP VIA EMAIL ON 23FEB2021, THE ONLY PROBLEM REPORTED WAS THE CONNECTION BETWEEN THE URINE METER TUBING AND THE INTRA-ABDOMINAL TUBING.

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

  MAUDE report 11283015 ↗
• MalfunctionJan 27, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN ATTEMPTED TO PLACE A URINARY CATHETER WITH INTRAABDOMINAL PRESSURE MONITORING DEVICE, THE CONNECTION WHERE THE 2 DEVICES CONNECT, KEPT COMING APART. THE USER PUT A MICROCLAVE ON THE END OF THE CONNECTION, SINCE THE PATIENT DID NEED THE MONITORING. REPORTED CATALOG NUMBERS WERE NGER3336, NGER3337, NGER0722. PER FOLLOW UP VIA EMAIL ON 23FEB2021, THE ONLY PROBLEM REPORTED WAS THE CONNECTION BETWEEN THE URINE METER TUBING AND THE INTRA-ABDOMINAL TUBING.

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

  MAUDE report 11236764 ↗