Aqua-Seal 8888571299 (UDI 10884521060968)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10884521060968), received between Jun 20, 2017 and Aug 26, 2025 — classified as 8 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (10 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED AN INFANT PATIENT WHO HAD PNEUMOTHORAX WHERE A DRAIN WAS INSERTED BUT AIR REACCUMULATED INTO THE CHEST. THE ONLY WAY TO RESOLVE THIS WAS TO MANUALLY SUCTION WITH A SYRINGE. THE CUSTOMER ASSUMED A BRONCHOPULMONARY FISTULA WAS PRESENT LEADING TO A CONTINUOUS AIR LEAK BUT DUE TO THE UNIQUE CONDITION THAT THE PATIENT HAD, THE PATIENT HAD THEIR CHEST OPENED AS PART OF THEIR MANAGEMENT. AT OPERATION, THE PATIENT DID NOT HAVE A PLEURAL LEAK IDENTIFIED AND YET AIR COULD BE FREELY ASPIRATED FROM THE CHEST. THE CUSTOMER STATED THAT THEY ARE CONCERNED THAT THERE IS A PROBLEM WITH THE UNDERWATER SEAL UNIT AS IT WAS REPLACED BY A DIFFERENT UNIT FROM ANOTHER MANUFACTURER AND THE AIR IN THE CHEST RESOLVED BOTH CLINICALLY AND ON X-RAY. THE DRAIN WAS REVIEWED ON MULTIPLE OCCASIONS BY MULTIPLE PROFESSIONALS DURING WARD ROUNDS TO ENSURE CORRECT USE AND THEN FINALLY BY 4 CONSULTANTS (ANAESTHETICS, PAEDIATRIC SURGERY X2 AND NEONATAL) AND NO ERRORS IN SET UP OR SUCTION APPLICATION WERE IDENTIFIED. ADDITIONAL INFORMATION RECEIVED ON 21AUG2025 STATED THAT THE PATIENT'S AGE IS UNKNOWN BUT UNDER 28 DAYS OLD. THE PATIENT HAD A CONGENITAL HEART DEFECT. THE OPENING OF THE CHEST WAS EXPLOR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22898828 ↗
• InjuryAug 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED AN INFANT PATIENT WHO HAD PNEUMOTHORAX WHERE A DRAIN WAS INSERTED BUT AIR REACCUMULATED INTO THE CHEST. THE ONLY WAY TO RESOLVE THIS WAS TO MANUALLY SUCTION WITH A SYRINGE. THE CUSTOMER ASSUMED A BRONCHOPULMONARY FISTULA WAS PRESENT LEADING TO A CONTINUOUS AIR LEAK BUT DUE TO THE UNIQUE CONDITION THAT THE PATIENT HAD, THE PATIENT HAD THEIR CHEST OPENED AS PART OF THEIR MANAGEMENT. AT OPERATION, THE PATIENT DID NOT HAVE A PLEURAL LEAK IDENTIFIED AND YET AIR COULD BE FREELY ASPIRATED FROM THE CHEST. THE CUSTOMER STATED THAT THEY ARE CONCERNED THAT THERE IS A PROBLEM WITH THE UNDERWATER SEAL UNIT AS IT WAS REPLACED BY A DIFFERENT UNIT FROM ANOTHER MANUFACTURER AND THE AIR IN THE CHEST RESOLVED BOTH CLINICALLY AND ON X-RAY. THE PATIENT AND DRAIN WERE TRANSPORTED TO ANOTHER HOSPITAL TO FACILITATE ECMO. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025 STATED THAT THE PATIENT'S AGE IS UNKNOWN BUT UNDER 28 DAYS OLD. THE PATIENT HAD A CONGENITAL HEART DEFECT. THE OPENING OF THE CHEST WAS EXPLORATORY SURGERY BASED ON THE ASSUMPTION THAT THERE WAS A BRONCHOPULMONARY FISTULA. THE PATIENT WAS TRANSFERRED TO AN ECMO SITE DUE TO THE UNRESOLVING PNEUMOTHORAX. THE PATIENT RECOVE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22898727 ↗
• MalfunctionJul 24, 2024Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THE DOCTOR FROM THE HOSPITAL STATED THAT WHEN MAKING THE CONNECTION AFTER THE PROCEDURE, HE COULDN¿T PERFORM A SUCTION, SO HE HAD TO USE A NEW EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820102 ↗
• MalfunctionJun 19, 2024Suction Failure; Suction Failure

  CUSTOMER REPORTS THAT THEY RECEIVED CALL FROM THE MOH NEONATAL ICU DOCTOR THAT THE AQUA SEAL DRAIN WAS NOT WORKING WELL AND STOP BUBBLING OR TIDAL LING AFTER A FEW MINUTES, THE PATIENT WAS ON SUCTION 20CM, WHEN THEY DO READJUST WORKS FOR FEW MINUTES THEN AGAIN STOPPED AND DON¿T DRAIN FLUID WELL. THE PATIENT WAS DIAGNOSED WITH PLEURAL EFFUSIONS ON A MECHANICAL VENTILATOR. THE CUSTOMER REQUESTED ANOTHER BRAND TO BE SUPPLIED FROM THE MOH STORE AND ONCE THEY REPLACED IT THERE WAS NO ISSUE AND WORKED VERY WELL. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO SUCTION. THE VOLUME OF WATER IN THE SEAL CHAMBER WAS 2CM AND THE SUCTION WAS SET TO 20 CM. THERE WERE NO KINKS IN THE TUBING AND THE PRODUCT WAS REPLACED WITH AN ATRIUM BRAND. THE PATIENT IS FINE WITH NO COMPLICATION AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567398 ↗
• MalfunctionJun 19, 2024Suction Failure; Suction Failure

  CUSTOMER REPORTS: THE PEDIATRIC DOCTOR USED THE AQUA SEAL FOR NEONATAL PATIENTS WITH PNEUMOTHORAX AND HAEMOTHORAX, WITH SUCTION FOR FLUID DRAIN. AFTER FEW MINUTES, THEY COULD NOT IDENTIFY ANY BUBBLING OR TIDAL LING AND THEY DO READJUSTMENT SEVERAL TIMES BUT AGAIN IT STOPPED WORKING WHICH AFFECTS THE WORKFLOW AND CONSUMES THE TIMING AND PROLONGS RECOVERY TIME FOR THE PATIENT. WHEN ANOTHER BRAND WAS USED, IT WAS WORKING WELL WITHOUT ANY ISSUE; THE BUBBLING, TIDAL LING AND DRAIN WORKING WELL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE BUBBLING DID WORK FOR A FEW MINUTES. THERE WAS NO SUCTION. THE VOLUME OF WATER IN THE SEAL CHAMBER WAS 2CM AND THE SUCTION WAS SET TO 20 CM. THERE WERE NO KINKS IN THE TUBING AND THE PRODUCT WAS REPLACED WITH AN ATRIUM BRAND. THERE WERE NO COMPLICATIONS AND PATIENT IS FINE AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567274 ↗
• MalfunctionJun 18, 2024Suction Failure; Suction Failure

  CUSTOMER REPORTS: SOME OF OUR CUSTOMERS HAVE USED THE AQUA SEAL CDU FOR THE NEONATAL PATIENTS, AND THEY COULD NOT IDENTIFY ANY TODDLING OR BUBBLING DURING THE OPERATION. THE DOCTORS ARE SUSPECTING THAT THIS MIGHT BE DUE TO A DEVICE FAILURE. THE CUSTOMERS ARE CONCERNED IF THE AQUA SEAL CDU IS DESIGNED TO BE USED FOR NEONATAL PATIENTS AS WELL AND THEY ARE LOOKING FOR AN OFFICIAL CONFIRMATION IN WRITING FROM THE MANUFACTURER. THEREFORE, YOU ARE KINDLY REQUESTED TO CLARIFY THE ABOVE FOR OUR CUSTOMERS ACKNOWLEDGEMENT AND LATER USAGE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS 9 MONTHS OLD. THE VOLUME OF WATER IN THE SEAL CHAMBER WAS 2CM AND THE SUCTION WAS SET TO 20 CM. THERE WERE NO KINKS IN THE TUBING AND THE PRODUCT WAS REPLACED WITH AN ATRIUM BRAND. THE PATIENT IS FINE WITH NO COMPLICATION. THERE WAS BUBBLING AND TIDELING WHICH PROVIDED SUCTION FOR A FEW MINUTES AND IT STOPPED WORKING COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563773 ↗
• MalfunctionAug 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE DOCTOR ASKED FOR ADVICE WITH REGARDS TO STEPPING DOWN THE SUCTION FROM THE SUCTION CONTROL CHAMBER OF THE AQUA-SEAL CHEST DRAIN UNIT - HOW TO REDUCE THE FLUID IN THE SUCTION CONTROL CHAMBER. THERE IS NO INFORMATION IN THE IFU ABOUT THIS. WITHIN CONVERSATION, IT WAS MENTIONED THAT BLUE DYE WAS NOTICED IN THE SUCTION CONTROL CHAMBER. THIS WAS NOTICED AS THE CDU WAS BEING DISCONNECTED DURING CLAMPING OFF. IT IS UNKNOWN IF THE WALL SUCTION WAS LEFT ON. BLUE DYE FROM THE WATER SEAL CHAMBER WAS NOTICED IN THE SUCTION CONTROL CHAMBER AFTER USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509469 ↗
• MalfunctionMar 22, 2023Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT ON ONE OCCASION LAST WEEK (W/C 20TH FEBRUARY) THE SUCTION CONTROL CHAMBER CONTINUED BUBBLING AFTER THE SUCTION HAD BEEN TURNED OFF. THEY REPLACED THE CDU WITH A NEW AQUASEAL UNIT AND THE ISSUE RESOLVED. THERE WAS NO PROBLEM FOR THE PATIENT BECAUSE OF THIS ISSUE. ADDITIONAL INFORMATION RECEIVED: THERE WAS BUBBLING IN BOTH THE WATER SEAL CHAMBER AND THE SUCTION CONTROL CHAMBER. THE CUSTOMER MENTIONED THAT WHEN THE SUCTION WAS TURNED OFF, BUBBLING CONTINUED IN THE SUCTION CONTROL CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589965 ↗
• MalfunctionSep 14, 2022Suction Problem; Suction Problem

  CUSTOMER REPORTS: DURING USE ON A PATIENT, THE HOSE THAT CONNECTS THE EQUIPMENT COLLAPSED SEVERAL TIMES. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6)2022 THERE WAS A LEAK THAT DID NOT ALLOW THE DEVICE TO BE USED PROPERLY BUT THE USER DID NOT IDENTIFY THE EXACT LOCATION OF THE LEAK. THERE WAS DIMINISHED SUCTION AND WHEN THE USER SAW THAT THE WATER SEAL WAS NOT WORKING PROPERLY, THEY TRIED TO FIX IT BUT DECIDED TO USE A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422337 ↗
• MalfunctionMay 12, 2022Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT IT WAS NECESSARY TO CHANGE THE ADULT THORACIC DRAINAGE SYSTEM FOR ONE OF THE SAME CAPACITY BECAUSE THE COLUMNS WERE MIXED WITHOUT THE EQUIPMENT FALLING. IT CAUGHT THEIR ATTENTION TO SEE THAT THE WATER FROM THE WATER SEAL THAT IS COLORED BLUE WAS IN THE LAST COLUMN OF THE DRAIN. THERE WAS NO PATIENT INJURY. THE DEVICE WAS BEING OPERATED IN THE HOSPITAL AT THE TIME OF THIS EVENT. THERE WAS NO RECIDIVISM. THERE IS NO PHOTOGRAPHIC OR PHYSICAL EVIDENCE OF THE MEDICAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14372294 ↗
• MalfunctionApr 21, 2022Decrease in Suction; Leak/Splash; Decrease in Suction; Leak/Splash

  THE CUSTOMER REPORTED AN ISSUE IN THE SEALING CAP RESULTING IN THE LOSS OF NEGATIVE PRESSURE CAUSING LOSS OF DRAINAGE OF THE PATIENT'S LEFT PLEURAL EFFUSION.

  Patient problems: Insufficient Information

  MAUDE report 14171665 ↗
• InjuryApr 21, 2022Decrease in Suction; Leak/Splash; Decrease in Suction; Leak/Splash

  THE CUSTOMER REPORTED THAT THE PLEUROVAC CAP DOES NOT SEAL, CAUSING LOSS OF NEGATIVE PRESSURE IN THE RIGHT LUNG TUBE, LEADING TO DECREASED DRAINAGE OF THE HEMOTHORAX CAUSING A RESIDUAL RIGHT PNEUMOTHORAX OF THE PATIENT.

  Patient problems: Pneumothorax

  MAUDE report 14171339 ↗
• MalfunctionDec 10, 2021Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THE DEVICE HAD AN ISSUE WITH THE PRESSURE REGULATING KEY OF THE PLEUROVAC. PER ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER, THE PRESSURE REGULATOR WAS NOT WORKING PROPERLY. THERE WERE SUCTION ISSUES AT THE BEGINNING OF USE UNTIL THE PRESSURE REGULATOR DID NOT WORK WELL. AS A RESULT, THE DEVICE WAS REPLACED WITH THE SAME MODEL. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT HAS LEFT THE INSTITUTION SO THERE IS NO CURRENT STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977593 ↗
• MalfunctionJul 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT ONE OF THE HOSES DISCONNECTED FROM THE DRAIN AND CANNOT BE RECONNECTED AS THERE IS NO VACUUM GENERATION IN THE CIRCUIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100516 ↗
• MalfunctionDec 11, 2020Suction Failure; Suction Failure

  THE CUSTOMER REPORTED THAT WHEN CONNECTING THE EQUIPMENT, IT DOES NOT VACUUM/DOES NOT SUCK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10993732 ↗
• MalfunctionNov 11, 2020Suction Failure; Suction Failure

  THE CUSTOMER REPORTED THERE WAS NO SUCTION, THE UNIT DID NOT WORK. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10825387 ↗
• MalfunctionOct 29, 2020Decrease in Suction

  CUSTOMER REPORTS: THE SEALING CHAMBER IS BEING SUCKED AGAINST THE WALL AFTER 30 MINUTES OF BEING CONNECTED TO PATIENT. THE UNIT/S WORKED PROPERLY FOR 30 MINUTES BUT AFTER THAT THE SUCTION STARTED TO DECREASE AND THE BLUE SEALING LIQUID WAS SUCKED TO THE WALL.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 10757862 ↗
• MalfunctionOct 29, 2020Decrease in Suction; Decrease in Suction

  CUSTOMER REPORTS: THE SEALING CHAMBER IS BEING SUCKED TO THE WALL AFTER 30 MINUTES OF BEING CONNECTED TO PATIENT. THE UNIT/S WORKED PROPERLY FOR 30 MINUTES BUT AFTER THAT THE SUCTION STARTED TO DECREASE AND THE BLUE SEALING LIQUID WAS SUCKED AGAINST THE WALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10757177 ↗
• MalfunctionOct 29, 2020Decrease in Suction; Decrease in Suction

  CUSTOMER REPORTS: THE SEALING CHAMBER IS BEING SUCKED TO THE WALL AFTER 30 MINUTES OF BEING CONNECTED TO PATIENT. THE UNIT/S WORKED PROPERLY FOR 30 MINUTES BUT AFTER THAT THE SUCTION STARTED TO DECREASE AND THE BLUE SEALING LIQUID WAS SUCKED AGAINST THE WALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10756818 ↗
• MalfunctionOct 29, 2020Decrease in Suction; Decrease in Suction

  CUSTOMER REPORTS: THE SEALING CHAMBER IS BEING SUCKED TO THE WALL AFTER 30 MINUTES OF BEING CONNECTED TO PATIENT. THE UNIT/S WORKED PROPERLY FOR 30 MINUTES BUT AFTER THAT THE SUCTION STARTED TO DECREASE AND THE BLUE SEALING LIQUID WAS SUCKED AGAINST THE WALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10756624 ↗
• MalfunctionOct 29, 2020Decrease in Suction; Decrease in Suction

  CUSTOMER REPORTS: THE SEALING CHAMBER IS BEING SUCKED TO THE WALL AFTER 30 MINUTES OF BEING CONNECTED TO PATIENT. THE UNIT/S WORKED PROPERLY FOR 30 MINUTES BUT AFTER THAT THE SUCTION STARTED TO DECREASE AND THE BLUE SEALING LIQUID WAS SUCKED AGAINST THE WALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10756348 ↗
• MalfunctionOct 28, 2020Decrease in Suction; Decrease in Suction

  THE CUSTOMER REPORTED THE UNIT WAS WORKING PROPERLY AT FIRST BUT THE SUCTION STARTED TO DECREASE AND THE BLUE SEALING LIQUID WAS SUCKED TO THE WALL. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10747561 ↗
• MalfunctionOct 28, 2020Decrease in Suction; Decrease in Suction

  THE CUSTOMER REPORTED THE UNIT WAS WORKING PROPERLY AT FIRST BUT THE SUCTION STARTED TO DECREASE AND THE BLUE SEALING LIQUID WAS SUCKED TO THE WALL. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10747435 ↗
• MalfunctionMar 16, 2020Suction Failure; Suction Failure

  THE CUSTOMER REPORTED THAT THE PLEUROVAC DOES NOT VACUUM/SUCTION.

  Patient problems: No Code Available

  MAUDE report 9835858 ↗
• InjuryFeb 19, 2020Fluid/Blood Leak; Suction Problem; Fluid/Blood Leak; Suction Problem

  THE CUSTOMER REPORTED THAT THE PATIENT WAS CONNECTED TO THORACIC DRAINAGE WHICH PRESENTS A PERMANENT BUBBLE THAT CAUSED THE WATER TO RISE ABOVE THE INITIAL LEVEL OF THE WATER SEAL AND THE WATER IN THE SUCTION CHAMBER EVAPORATE. ALSO, THE UNIDIRECTIONAL VALVE IS BIDIRECTIONAL AND IT DOES NOT WORK FOR POSITIVE SUCTION. RECEIVED ADDITIONAL INFORMATION ON 29-JAN-2020 STATING THAT A PATIENT WAS INVOLVED AND DEVELOPED PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 9729758 ↗